Calcium regulates many critical processes within the body, including muscle contraction, the heartbeat, and the release of hormones. But too much calcium can be a bad thing. In excess, it can lead to a host of diseases, such as severe muscle weakness, a fatal reaction to anesthesia or sudden cardiac death.
Now, using intense X-rays from the Stanford Synchrotron Radiation Lightsource (SSRL) at the Department of Energy's SLAC National Accelerator Laboratory, researchers have determined the detailed structure of a key part of the ryanodine receptor, a protein associated with calcium-related disease. Their results, which combine data from SSRL and the Canadian Light Source, pinpoint the locations of more than 50 mutations that cluster in disease "hotspots" along the receptor.
"Until now, no one could tell where these disease mutations were located or what they were doing," said principal investigator Filip Van Petegem of the University of British Columbia in Vancouver.
The ryanodine receptor controls the release of calcium ions from a storehouse within skeletal-muscle and heart-muscle cells as needed to perform critical functions. Previous studies at lower resolution indicated that mutations cluster in three regions along the receptor, but without more detailed information it remained unclear exactly how they contributed to disease.
In a study published this week in Nature, Van Petegem and his group describe the structure of one of these hotspots in extremely fine detail and predict how the mutations might cause the receptor to malfunction and release calcium too soon.
The receptor is made up of more than 20,000 molecules called amino acids. Van Petegem's group studied a string of about 560 amino acids, where they found 57 mutations. In 56 cases, the mutations involved a change in a single amino acid, while the last one involved a deletion of 35 amino acids from the string.
"These mutations most likely cause the same disease effects, but a severe mutation leads to stronger symptoms, and doesn't require as big of a stimulus to induce disease," Van Petegem said.
In the heart, the receptor is stimulated to open about once a second when the body is at rest, sending regular pulses of calcium into the rest of the cell. In skeletal muscles, the timing of the pulses is determined by how often the muscles contract. Each time the receptor opens, certain amino acids rearrange themselves to facilitate the calcium release. Mutations can disrupt this process by causing the receptor to open either earlier or more easily than it should.
This premature release of calcium produces extra electrical signals within the cells. In skeletal muscle, this can lead to fatal rises in body temperature under certain anesthetics, or the failure of major muscles. In cardiac muscle it can trigger an arrhythmia, resulting in sudden cardiac death. While it is difficult to determine the exact number of people with these mutations, it is estimated that as many as one in 10,000 may be at risk for disease.
"Thanks to the technological capabilities at SSRL, we were able to rapidly screen hundreds of crystallized samples of this receptor protein to find ones with the best quality, giving the best structure. This study is a good first step toward designing new molecules that could be used as a drug," Van Petegem said. "These mutations could be a very promising therapeutic target for treating heart disease."
Future studies at SSRL and other synchrotron facilities will map out other receptor hotspots where these disease mutations cluster and use the detailed information to better understand the complex functions of the protein.
"It is very exciting to see the significant impact of our advanced structural biology technologies in helping users address difficult projects," said SSRL staff scientist Michael Soltis.
This research was supported by the Canadian Institutes of Health Research. The Stanford Synchrotron Radiation Lightsource is supported by the U. S. Department of Energy Office of Science. SLAC National Accelerator Laboratory is a multi-program laboratory exploring frontier questions in photon science, astrophysics, particle physics and accelerator research. Located in Menlo Park, California, SLAC is operated by Stanford University for the U.S. Department of Energy Office of Science.
Source:
Melinda Lee
DOE/SLAC National Accelerator Laboratory
вторник, 30 августа 2011 г.
суббота, 27 августа 2011 г.
University Of Montreal And Hospital Maisonneuve-Rosemont To Receive Hip Society's John Charnley Award
A team of orthopedic surgeons and kinesiologists from the UniversitГ© de MontrГ©al and its affiliated Maisonneuve-Rosemont Hospital Research Centre will be honoured with the Hip Society's John Charnley Award - the most prestigious award in the field of hip surgery. The award will be presented on February 28, 2009, in Las Vegas.
As North American pioneers in the development of new knee and hip replacement technologies, Drs. Pascal-André Vendittoli, Martin Lavigne, and Alain Roy, in collaboration with kinesiologists Marc Therrien, Julie Nantel, and François Prince, have carried out an important study assessing the performance of hip resurfacing surgery compared with total hip replacement using large-diameter heads.
"The Hip Society's John Charnley Award is the highest honour our team could have ever expected to receive," said Dr. Vendittoli.
Less invasive than total hip replacement
Drs. Roy, Vendittoli and Lavigne were the first in North America to introduce the use of a hip resurfacing prosthesis back in 2003. The Durom® prosthesis, which the team used, is a small metal cup that's placed on the femoral head. It is used as an alternative to a total hip prosthesis, which is usually implanted in the femur. Hip resurfacing is hugely advantageous because it is bone-conserving and much less invasive than a total hip replacement.
For the first time, these studies provide solid scientific data highlighting the pros and cons of new joint replacement implants for active young subjects.
As part of a new 24-month study, the research team compared hip resurfacing and total hip prostheses with metal on metal surfaces of 28 mm. Their findings revealed that hip resurfacing has functional superiority and little chance of luxation. This study will be published in the American Journal of Bone and Joint Surgery in 2009.
The researchers brought their investigation one step further with a second study, where they conducted a comparative on hip resurfacing and total hip prostheses with metal on metal surfaces of large diameter. This second study - conducted without any of the patients' or examiners' knowledge of which implant was used - is being recognized with the John Charnley Award. Sophisticated methods such as Vicon cameras were used to examine all of the patients. The study showed that both groups received equivalent results after six months, and concluded that the single advantage of hip resurfacing over total hip prostheses of large diameter is femoral conservation.
This release is available in French.
Arthrosis of the hip joint, or coxarthrosis, is the most common joint disorder after arthrosis of the knee and afflicts almost 15 percent of the population.
On the Web:
About the UniversitГ© de MontrГ©al: umontreal.ca/english/index.htm
About the HГґpital Maisonneuve-Rosemont: maisonneuve-rosemont/pages/H/index.aspx
Source: Pascal Mailhot
University of Montreal
As North American pioneers in the development of new knee and hip replacement technologies, Drs. Pascal-André Vendittoli, Martin Lavigne, and Alain Roy, in collaboration with kinesiologists Marc Therrien, Julie Nantel, and François Prince, have carried out an important study assessing the performance of hip resurfacing surgery compared with total hip replacement using large-diameter heads.
"The Hip Society's John Charnley Award is the highest honour our team could have ever expected to receive," said Dr. Vendittoli.
Less invasive than total hip replacement
Drs. Roy, Vendittoli and Lavigne were the first in North America to introduce the use of a hip resurfacing prosthesis back in 2003. The Durom® prosthesis, which the team used, is a small metal cup that's placed on the femoral head. It is used as an alternative to a total hip prosthesis, which is usually implanted in the femur. Hip resurfacing is hugely advantageous because it is bone-conserving and much less invasive than a total hip replacement.
For the first time, these studies provide solid scientific data highlighting the pros and cons of new joint replacement implants for active young subjects.
As part of a new 24-month study, the research team compared hip resurfacing and total hip prostheses with metal on metal surfaces of 28 mm. Their findings revealed that hip resurfacing has functional superiority and little chance of luxation. This study will be published in the American Journal of Bone and Joint Surgery in 2009.
The researchers brought their investigation one step further with a second study, where they conducted a comparative on hip resurfacing and total hip prostheses with metal on metal surfaces of large diameter. This second study - conducted without any of the patients' or examiners' knowledge of which implant was used - is being recognized with the John Charnley Award. Sophisticated methods such as Vicon cameras were used to examine all of the patients. The study showed that both groups received equivalent results after six months, and concluded that the single advantage of hip resurfacing over total hip prostheses of large diameter is femoral conservation.
This release is available in French.
Arthrosis of the hip joint, or coxarthrosis, is the most common joint disorder after arthrosis of the knee and afflicts almost 15 percent of the population.
On the Web:
About the UniversitГ© de MontrГ©al: umontreal.ca/english/index.htm
About the HГґpital Maisonneuve-Rosemont: maisonneuve-rosemont/pages/H/index.aspx
Source: Pascal Mailhot
University of Montreal
среда, 24 августа 2011 г.
PAC Looks At Osteoporosis - Our $7b Health Problem, Australia
Osteoporosis is a major public health problem in Australia which sees, on average, 260
people hospitalised every day with an osteoporotic fracture - or one person every six
minutes.
The total annual cost to the community of such hospitalisations as well as the treatment for
osteoporosis means the condition costs $7 billion in total.
Osteoporosis is characterised by low bone mass, micro-architectural deterioration of bone,
bone fragility and increased risk of fracture.
The rate of incidence is staggering with osteoporotic fractures occurring in 1 in 2 women
and 1 in 3 men over the age of 60.
Pharmacists need to understand the condition and how best to treat it and those attending
the Pharmacy Australia Congress in October will be able to hear one of the country's leading
pharmacy presenters, Professor Peter Carroll, speak on the subject of Osteoporosis -
Prevention and Treatment.
Professor Carroll says non-modifiable risk factors for developing osteoporosis include
advanced age, being female, early menopause and family history.
Modifiable risk factors include low body weight or slim build, inadequate calcium intake, low
Vitamin D levels, sedentary lifestyle, smoking and some medications such as glucocorticoids
and anticonvulsants.
"Recent evidence also suggests that therapy with selective serotonin reuptake inhibitors,
proton pump inhibitors or glitazones may increase the risk of fracture," he says.
"Lifestyle issues, adequate calcium intake and appropriate vitamin D levels play a major role
in the prevention of osteoporosis, and the role of the pharmacist in counselling patients about
these issues will be discussed."
Apart from calcium and vitamin D supplements, medications used in the treatment of
osteoporosis include the bisphosphonates, raloxifene, strontium ranelate and teriparatide.
Professor Carroll will examine the place of each of these medications in the treatment of
osteoporosis, including their side effect profiles.
The duration of bisphosphonate therapy, as well as bisphosphonate induced osteonecrosis of
the jaw, will also be discussed.
This year's PAC in Sydney being held at the Sydney Hilton from 15-18 October under the
overarching theme of Securing Your Practice Advantage.
Source
Pharmaceutical Society of Australia
people hospitalised every day with an osteoporotic fracture - or one person every six
minutes.
The total annual cost to the community of such hospitalisations as well as the treatment for
osteoporosis means the condition costs $7 billion in total.
Osteoporosis is characterised by low bone mass, micro-architectural deterioration of bone,
bone fragility and increased risk of fracture.
The rate of incidence is staggering with osteoporotic fractures occurring in 1 in 2 women
and 1 in 3 men over the age of 60.
Pharmacists need to understand the condition and how best to treat it and those attending
the Pharmacy Australia Congress in October will be able to hear one of the country's leading
pharmacy presenters, Professor Peter Carroll, speak on the subject of Osteoporosis -
Prevention and Treatment.
Professor Carroll says non-modifiable risk factors for developing osteoporosis include
advanced age, being female, early menopause and family history.
Modifiable risk factors include low body weight or slim build, inadequate calcium intake, low
Vitamin D levels, sedentary lifestyle, smoking and some medications such as glucocorticoids
and anticonvulsants.
"Recent evidence also suggests that therapy with selective serotonin reuptake inhibitors,
proton pump inhibitors or glitazones may increase the risk of fracture," he says.
"Lifestyle issues, adequate calcium intake and appropriate vitamin D levels play a major role
in the prevention of osteoporosis, and the role of the pharmacist in counselling patients about
these issues will be discussed."
Apart from calcium and vitamin D supplements, medications used in the treatment of
osteoporosis include the bisphosphonates, raloxifene, strontium ranelate and teriparatide.
Professor Carroll will examine the place of each of these medications in the treatment of
osteoporosis, including their side effect profiles.
The duration of bisphosphonate therapy, as well as bisphosphonate induced osteonecrosis of
the jaw, will also be discussed.
This year's PAC in Sydney being held at the Sydney Hilton from 15-18 October under the
overarching theme of Securing Your Practice Advantage.
Source
Pharmaceutical Society of Australia
воскресенье, 21 августа 2011 г.
Potential New Therapy For Spinal Cord Injury-Induced Spasticity And Rigidity
Research led by scientists at the University of California, San Diego (UCSD) School of Medicine has identified a target with potential as an effective new therapy for chronic spasticity and rigidity, a painful condition that often results from spinal cord injury.
In work with rats, Martin Marsala, M.D., a professor in the Department of Anesthesiology at the University of California, San Diego (UCSD) School of Medicine, demonstrated that an AMPA receptor antagonist called NGX424 (tezampanel), being developed by TorreyPines Therapeutics, Inc., of La Jolla, California, is highly potent in suppressing spasticity and rigidity. The study will be published in the October 17 issue of the Journal of Neuroscience.
Paraplegia from spinal cord ischemia is a serious complication that occurs in 20 to 40 percent of patients undergoing a surgical process called aortic cross-clamping. When the surgeon works on the aorta to correct a potentially lethal aneurysm, this large vessel carrying all of the blood flow from the heart must be temporarily blocked. If clamping occurs for more than 30 minutes, the procedure can result in the loss of specialized spinal cord neurons called spinal inhibitory neurons. Loss of these neurons can lead to irreversible spasticity and rigidity, or loss of muscle control, in the lower limbs.
"This exaggerated muscle tone, or uncontrolled spasms, is a serious complication of either ischemic or traumatic injury to the spinal cord -- such as injuries resulting from a diving or car accident," said Marsala. Several other conditions can lead to spasticity/rigidity, including brain trauma, multiple sclerosis, cerebral palsy or Parkinson's disease -- all of which lead to increased peripheral muscle tone.
The most effective treatment for the spastic muscle condition -- which results in pain and tremendous spasms, even in those patients who have partial motor recovery -- has been a drug called Baclofen, a GABA-B receptor agonist that is delivered either systemically or spinally to patients. However, according to Marsala, patients taking this drug often develop tolerance and need increased dosage to achieve the same effect.
"A new therapy to control spasticity is very important," said lead author Michael P. Hefferan, Ph.D., of UCSD's Department of Anesthesiology. "This AMPA receptor blockade offers a novel means of reducing the spasticity and rigidity in muscles because it works through a totally different receptor system than current drugs being used."
Spinal spasticity is the result of increased spinal neuronal excitability. The NGX424 compound -- which is delivered via intrathecal catheters that inject the drug into the fluid surrounding the spinal cord -- suppresses the AMPA-mediated neuronal excitation, relieving otherwise increased muscle tone.
The authors also demonstrated that intrathecal delivery of GluR1 antisense (a treatment that blocks expression of one of the subunits in the AMPA receptor complex) provides a similar antispasticity effect. This further demonstrates a role for AMPA receptors in spasticity and rigidity, and indicates that blockade of this subunit by NGX424 likely plays a key role in the observed antispasticity effect.
Marsala added that additional large animal safety testing will be required before the researchers can consider clinical trials in humans. However, the rat data from this study indicates no toxicity using infused NGX424. Subcutaneous delivery of the drug is currently being evaluated for treating migraines.
Additional researchers include Karolina Kucharova, Kiyohiko Kinjo, Osamu Kakinohana, Tony L. Yaksh, UCSD Department of Anesthesiology; Gabriella Sekerkova, Feinberg School of Medicine, Northwestern University; Seiya Nakamura and Tatsuya Fuchigami, UCSD Department of Anesthesiology and University of the Ryukyus, Okinawa, Japan; Zoltan Tomori, Institute of Experimental Physics, Slovak Academy of Scineces; and Neil Kurtz, TorreyPines Therapeutics, Inc., La Jolla.
Funding for the research was provided by the National Institutes of Health, an American Heart Association post-doctoral fellowship and TorreyPines Therapeutics Inc.
Source: Debra Kain
University of California - San Diego
In work with rats, Martin Marsala, M.D., a professor in the Department of Anesthesiology at the University of California, San Diego (UCSD) School of Medicine, demonstrated that an AMPA receptor antagonist called NGX424 (tezampanel), being developed by TorreyPines Therapeutics, Inc., of La Jolla, California, is highly potent in suppressing spasticity and rigidity. The study will be published in the October 17 issue of the Journal of Neuroscience.
Paraplegia from spinal cord ischemia is a serious complication that occurs in 20 to 40 percent of patients undergoing a surgical process called aortic cross-clamping. When the surgeon works on the aorta to correct a potentially lethal aneurysm, this large vessel carrying all of the blood flow from the heart must be temporarily blocked. If clamping occurs for more than 30 minutes, the procedure can result in the loss of specialized spinal cord neurons called spinal inhibitory neurons. Loss of these neurons can lead to irreversible spasticity and rigidity, or loss of muscle control, in the lower limbs.
"This exaggerated muscle tone, or uncontrolled spasms, is a serious complication of either ischemic or traumatic injury to the spinal cord -- such as injuries resulting from a diving or car accident," said Marsala. Several other conditions can lead to spasticity/rigidity, including brain trauma, multiple sclerosis, cerebral palsy or Parkinson's disease -- all of which lead to increased peripheral muscle tone.
The most effective treatment for the spastic muscle condition -- which results in pain and tremendous spasms, even in those patients who have partial motor recovery -- has been a drug called Baclofen, a GABA-B receptor agonist that is delivered either systemically or spinally to patients. However, according to Marsala, patients taking this drug often develop tolerance and need increased dosage to achieve the same effect.
"A new therapy to control spasticity is very important," said lead author Michael P. Hefferan, Ph.D., of UCSD's Department of Anesthesiology. "This AMPA receptor blockade offers a novel means of reducing the spasticity and rigidity in muscles because it works through a totally different receptor system than current drugs being used."
Spinal spasticity is the result of increased spinal neuronal excitability. The NGX424 compound -- which is delivered via intrathecal catheters that inject the drug into the fluid surrounding the spinal cord -- suppresses the AMPA-mediated neuronal excitation, relieving otherwise increased muscle tone.
The authors also demonstrated that intrathecal delivery of GluR1 antisense (a treatment that blocks expression of one of the subunits in the AMPA receptor complex) provides a similar antispasticity effect. This further demonstrates a role for AMPA receptors in spasticity and rigidity, and indicates that blockade of this subunit by NGX424 likely plays a key role in the observed antispasticity effect.
Marsala added that additional large animal safety testing will be required before the researchers can consider clinical trials in humans. However, the rat data from this study indicates no toxicity using infused NGX424. Subcutaneous delivery of the drug is currently being evaluated for treating migraines.
Additional researchers include Karolina Kucharova, Kiyohiko Kinjo, Osamu Kakinohana, Tony L. Yaksh, UCSD Department of Anesthesiology; Gabriella Sekerkova, Feinberg School of Medicine, Northwestern University; Seiya Nakamura and Tatsuya Fuchigami, UCSD Department of Anesthesiology and University of the Ryukyus, Okinawa, Japan; Zoltan Tomori, Institute of Experimental Physics, Slovak Academy of Scineces; and Neil Kurtz, TorreyPines Therapeutics, Inc., La Jolla.
Funding for the research was provided by the National Institutes of Health, an American Heart Association post-doctoral fellowship and TorreyPines Therapeutics Inc.
Source: Debra Kain
University of California - San Diego
четверг, 18 августа 2011 г.
Short And Long-Term Efficacy Of Spinal Stabilisation System Investigated In Patients With Lower Back Pain
A new study announced today by Medtronic will investigate the short and long-term benefits of adding a spinal stabilisation system to a standard herniectomy procedure in patients with spinal disc herniation. The study is the first randomised control trial to assess the clinical benefit and patient perception of the relief of lower back pain in patients with spinal disc herniation, comparing a standard herniectomy versus a herniectomy supplemented with the DIAMпїЅ Spinal Stabilisation System.
"This new study is crucial to determine whether a spinal stabilisation system can help offer faster recovery time and reduce postoperative pain to patients with lower back pain undertaking a herniectomy and hence prevent or delay the need for spinal fusion," stated Dr. Ferdinand Krappel, an orthopaedic surgeon with Medizinisches Zentrum Kreis Hospital in Aachen, Germany, and a leading investigator of the DIAM study. "Compared to spinal fusion, this procedure is minimally invasive and it maintains the surgical site for future procedures if and when required."
It is estimated that more than 22 million people age 20 and older suffer from chronic back pain in Western Europe. One-third of these adults show evidence of herniated disc. Spinal disc herniation is also known as a slipped, ruptured or torn disc, and consists in a rupture of the spinal disc often occurring as a result of aging.
This multi-centre study expects to enroll 268 patients at 20 centres in six countries, including Belgium, Germany, Italy, Spain, Switzerland, and the United Kingdom. The study is the third of three planned randomised control trials investigating the benefits of the DIAM Spinal Stabilisation System in more than 1,000 patients in the United States and in Europe. The European trial endpoints include back pain relief at six months and reduction of disability at 12 months.
The herniectomy procedure takes approximately one hour and usually requires two to three days of hospitalisation. During the operation, the spinal stabilisation system is placed between the spinous processes (the visible ridges of the back) and is designed to act as a shock absorber that reduces loads on the surrounding vertebrae. The core of the DIAM System is made of silicone, while the outer mesh and tethers are made of medical-grade polyester. The flexible properties of the DIAM materials may also protect the integrity of the spinous process.
According to Lionel Hadjadjeba, vice president of the Spinal, Biologics and Navigation business at Medtronic, "Medtronic plays a leading role in the research on new device therapy for patients with chronic back pain, and learning more about the DIAM Spinal Stabilisation System will enable us to continue bringing therapies to market."
Back pain is one of the most common reasons for chronic disability and incapacity in the Western world.
About the Spinal Business at Medtronic
Medtronic's spinal business, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. The spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at medtronicspinal and its patient-education Web sites, back, iscoliosis, maturespine and necksurgery.
About Medtronic
Medtronic, Inc. (medtronic), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Medtronic
medtronic
"This new study is crucial to determine whether a spinal stabilisation system can help offer faster recovery time and reduce postoperative pain to patients with lower back pain undertaking a herniectomy and hence prevent or delay the need for spinal fusion," stated Dr. Ferdinand Krappel, an orthopaedic surgeon with Medizinisches Zentrum Kreis Hospital in Aachen, Germany, and a leading investigator of the DIAM study. "Compared to spinal fusion, this procedure is minimally invasive and it maintains the surgical site for future procedures if and when required."
It is estimated that more than 22 million people age 20 and older suffer from chronic back pain in Western Europe. One-third of these adults show evidence of herniated disc. Spinal disc herniation is also known as a slipped, ruptured or torn disc, and consists in a rupture of the spinal disc often occurring as a result of aging.
This multi-centre study expects to enroll 268 patients at 20 centres in six countries, including Belgium, Germany, Italy, Spain, Switzerland, and the United Kingdom. The study is the third of three planned randomised control trials investigating the benefits of the DIAM Spinal Stabilisation System in more than 1,000 patients in the United States and in Europe. The European trial endpoints include back pain relief at six months and reduction of disability at 12 months.
The herniectomy procedure takes approximately one hour and usually requires two to three days of hospitalisation. During the operation, the spinal stabilisation system is placed between the spinous processes (the visible ridges of the back) and is designed to act as a shock absorber that reduces loads on the surrounding vertebrae. The core of the DIAM System is made of silicone, while the outer mesh and tethers are made of medical-grade polyester. The flexible properties of the DIAM materials may also protect the integrity of the spinous process.
According to Lionel Hadjadjeba, vice president of the Spinal, Biologics and Navigation business at Medtronic, "Medtronic plays a leading role in the research on new device therapy for patients with chronic back pain, and learning more about the DIAM Spinal Stabilisation System will enable us to continue bringing therapies to market."
Back pain is one of the most common reasons for chronic disability and incapacity in the Western world.
About the Spinal Business at Medtronic
Medtronic's spinal business, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. The spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at medtronicspinal and its patient-education Web sites, back, iscoliosis, maturespine and necksurgery.
About Medtronic
Medtronic, Inc. (medtronic), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Medtronic
medtronic
понедельник, 15 августа 2011 г.
N Spine Receives 510(k) Clearance Of Its NFix II Dynamic Stabilization System For The Lumbar Spine
N Spine, Inc., a privately held San
Diego spinal implant company, today announced that it has received FDA
clearance of its NFix(TM) II dynamic pedicle screw and rod system for
stabilization of the lumbar spine as an adjunct to fusion. NFix(TM) II is
now commercially available in the United States.
"Interest from US surgeons in the NFix(TM) II Dynamic Stabilization
System has been extremely strong," said Sean Na, president and chief
executive officer of N Spine. "This enthusiasm reflects the appeal of our
unique design as well as the growing market adoption of dynamic rod
systems."
Outside of the US, early clinical results with the company's NFlex(TM)
Controlled Motion System have been very favorable. NFlex(TM) is the first
product to market that controls shear motion, while allowing a more
physiologic level of flexion, extension and lateral bending. NFlex(TM) is
CE marked for non-fusion indications, and is the subject of an N Spine
sponsored prospective randomized trial comparing it to the Zimmer
Dynesys(R) device.
"I'm very pleased with the results of the three-month motion x-rays on
the first NFlex(TM) patients," stated Hansen Yuan, MD, who is a member of
the N Spine, Inc. Scientific Advisory Board. "It's clear that motion is
maintained."
With clearance of the NFix(TM) II Dynamic Stabilization System for
fusion surgery, and NFlex(TM) as a stand alone motion preservation device
for non-fusion outside the US, the company is well positioned to leverage
its proprietary designs in the $5 billion spinal implant market. "There are
a significant number of patients who will benefit from motion preserving
technologies," stated Na.
Recently, N Spine closed on $2.75 million debt financing by Silicon
Valley Bank and has raised a total of $7.1 million in equity and
non-dilutive financing.
About N Spine, Inc
N Spine, Inc. is a privately held San Diego spine company that designs
and develops devices for dynamic stabilization and motion preservation of
the lumbar spine via minimally invasive surgery (MIS). The company is
positioned to become the market leader in this emerging field.
N Spine has developed a superior platform technology that will serve a
broad set of indications, successfully recruited executives with extensive
spine industry experience, and created an internationally renowned
Scientific Advisory Board.
N Spine, Inc.
n-spine/
Diego spinal implant company, today announced that it has received FDA
clearance of its NFix(TM) II dynamic pedicle screw and rod system for
stabilization of the lumbar spine as an adjunct to fusion. NFix(TM) II is
now commercially available in the United States.
"Interest from US surgeons in the NFix(TM) II Dynamic Stabilization
System has been extremely strong," said Sean Na, president and chief
executive officer of N Spine. "This enthusiasm reflects the appeal of our
unique design as well as the growing market adoption of dynamic rod
systems."
Outside of the US, early clinical results with the company's NFlex(TM)
Controlled Motion System have been very favorable. NFlex(TM) is the first
product to market that controls shear motion, while allowing a more
physiologic level of flexion, extension and lateral bending. NFlex(TM) is
CE marked for non-fusion indications, and is the subject of an N Spine
sponsored prospective randomized trial comparing it to the Zimmer
Dynesys(R) device.
"I'm very pleased with the results of the three-month motion x-rays on
the first NFlex(TM) patients," stated Hansen Yuan, MD, who is a member of
the N Spine, Inc. Scientific Advisory Board. "It's clear that motion is
maintained."
With clearance of the NFix(TM) II Dynamic Stabilization System for
fusion surgery, and NFlex(TM) as a stand alone motion preservation device
for non-fusion outside the US, the company is well positioned to leverage
its proprietary designs in the $5 billion spinal implant market. "There are
a significant number of patients who will benefit from motion preserving
technologies," stated Na.
Recently, N Spine closed on $2.75 million debt financing by Silicon
Valley Bank and has raised a total of $7.1 million in equity and
non-dilutive financing.
About N Spine, Inc
N Spine, Inc. is a privately held San Diego spine company that designs
and develops devices for dynamic stabilization and motion preservation of
the lumbar spine via minimally invasive surgery (MIS). The company is
positioned to become the market leader in this emerging field.
N Spine has developed a superior platform technology that will serve a
broad set of indications, successfully recruited executives with extensive
spine industry experience, and created an internationally renowned
Scientific Advisory Board.
N Spine, Inc.
n-spine/
пятница, 12 августа 2011 г.
Once-Monthly Bonviva(R), An Important Advance In The Treatment Of Postmenopausal Osteoporosis
Data presented this week at the 33rd European Symposium on Calcified Tissues (ECTS) adds to the growing body of evidence that the only once-monthly bisphosphonate, Bonviva(R) (ibandronic acid), is proving to be an important step forwards in the treatment of osteoporosis. The data being presented at the ECTS meeting supports existing evidence in showing that Bonviva:
-- is highly effective1
-- is well-tolerated2
-- has a convenient once monthly dosing schedule that is preferred by women, which may therefore help them to stay on therapy3
Bonviva's benefit of less frequent dosing (compared to weekly bisphosphonates) has the potential to play a significant role to play in helping women with postmenopausal osteoporosis stay on their treatment. This is of particular importance as adherence to treatment is a major problem in the management of osteoporosis, with more than 50% of patients on a once-weekly bisphosphonate stopping treatment within a year.4,5 'Real life' efficacy can only be truly achieved if postmenopausal patients continue to take an effective treatment for a long period of time.
The Growing Body of Evidence
Bonviva, efficacy in osteoporosis with only one tablet once a month
Bonviva, a highly effective bisphosphonate, has been shown to reduce spinal fractures by 62% in patients with postmenopausal osteoporosis.6 New analyses from the MOBILE 2-year (Monthly Oral iBandronate In LadiEs) study, presented at the 33rd European Symposium on Calcified Tissues (ECTS), confirm once-monthly Bonviva is highly effective at increasing lumbar spine and hip bone mineral density (BMD), an accepted surrogate for fracture risk reduction.1
Bonviva - a well-tolerated treatment option
Associated side effects are one of the main reasons patients stop taking their osteoporosis treatment.7 MOBILE showed that two years treatment with Bonviva once monthly was not associated with an increased incidence of upper gastrointestinal (GI) adverse events versus the daily dose. In addition, data showed there was no evidence that treatment led to an increased withdrawal due to upper GI adverse events compared to the 2.5mg daily regimen over two-years.2
Patient preference for once monthly dosing
Patient preference is becoming increasingly recognised as an important factor in ensuring treatment is taken for the long term as prescribed. Also presented at ECTS, the results of the BALTO II (Bonviva ALendronate Trial in Osteoporosis) multi-centre clinical study suggest that once-monthly bisphosphonate dosing has the potential to improve adherence, with over 70% of postmenopausal women with osteoporosis* preferring a once-monthly bisphosphonate, finding it more convenient than a once-weekly option.3
BALTO II examined the treatment preferences of 321 women with postmenopausal osteoporosis in centres across the US and Europe and of the 93% who expressed a preference, * 70.6% preferred treatment with Bonviva taken once a month and 76.6% found it more convenient than weekly alendronate. 3 In the study, the most common reason women gave for their preference was that one tablet a month is easier to follow for a long time.3
Helping women to stay on therapy
Also at ECTS, the study design for PERSIST (PERsistence Study of Ibandronate verSus alendronaTe) was presented for the first time. This is a six-month prospective, randomised, open label, multicentre study of over 1,000 women with postmenopausal osteoporosis.8 PERSIST uses a study design that is as close to 'real life' as possible, with patients given prescriptions by their GP and required to visit the local pharmacist to receive the medication, as happens in normal practice.8 The results from the PERSIST trial will show whether patients on a monthly treatment programme stay on treatment longer than those taking a weekly option.
*who had tried both monthly and weekly treatments and who had expressed a preference
About Bonviva
-- Bonviva, a potent and highly effective bisphosphonate, has been studied to date in clinical trials involving over 13,000 patients.
-- Once-monthly Bonviva is indicated for the treatment of osteoporosis in postmenopausal women. It works by reducing elevated bone turnover, increasing bone mineral density and reducing the incidence of vertebral fractures.
-- Bonviva is the only nitrogen containing bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.6
-- Bonviva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, oesophagitis and oesophageal or gastric ulcer.
-- Once-monthly oral Bonviva received European Union approval in September 2005 and Swiss medic approval in August 2005. Once monthly Boniva (the brand name in the US) received FDA approval in March 2005.
Roche/GSK Collaboration
In December 2001, F Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (roche).
About GSK
GSK, one of the world's leading research-based pharmaceutical and healthcare
companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
All trademarks used or mentioned in this release are legally protected.
Roche Healthkiosk, Osteoporosis:
health-kiosk.ch/start_osteo.htm
GSK website:
gsk
References
1. Stone M, Henson J, Stakkesatd JA, Hughes C, Mairon N, et al. Once-monthly ibandronate dosing is more effective than daily dosing for improving bone mineral density: MOBILE 2-year analysis. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.
2. Delmas PD, Stone M, Stakkestad JA, Leigh C, Hiltbrunner V et al. Upper gastrointestinal safety and tolerability profile of once-monthly oral ibandronate: MOBILE 2-year analysis. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.
3. Benhamou C-L, Licata AA, Devas V, Masanauskaite D, Hadji P. Patient preference for once-monthly oral ibandronate and weekly oral alendronate in postmenopausal osteoporosis: the BALTO study. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.
4. Cowell W, Fulford-Smith A, Poultney S. Adherence with bisphosphonate treatment for osteoporosis in UK patients. Poster presented the second joint meeting of the European Calcified Tissue Society and the International Bone Mineral Society, Geneva, 25-29 June 2005.
5. Cramer J, Amonkar MM, Hebborn A and Suppapanya N. Does dosing regimen impact persistence with bisphosphonate therapy among postmenopausal osteoporotic women? Journal Bone Mineral Research 2004; 19 Suppl 1: S448
6. Chesnut CH, Skag A, Christiansen C, Recker R, Stakkestad JA et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral Research 2004;19(8):1241-49.
7. IPSOS Health, European Survey of Physicians and women with osteoporosis, January-April 2005. Sponsored by Roche/GSK.
8. Cooper, A.L (on behalf of the PERSIST Study Investigators). Rationale and design of the PERSIST study (PERsistence Study of Ibandronate verSus alendronaTe). Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.
View drug information on Boniva.
-- is highly effective1
-- is well-tolerated2
-- has a convenient once monthly dosing schedule that is preferred by women, which may therefore help them to stay on therapy3
Bonviva's benefit of less frequent dosing (compared to weekly bisphosphonates) has the potential to play a significant role to play in helping women with postmenopausal osteoporosis stay on their treatment. This is of particular importance as adherence to treatment is a major problem in the management of osteoporosis, with more than 50% of patients on a once-weekly bisphosphonate stopping treatment within a year.4,5 'Real life' efficacy can only be truly achieved if postmenopausal patients continue to take an effective treatment for a long period of time.
The Growing Body of Evidence
Bonviva, efficacy in osteoporosis with only one tablet once a month
Bonviva, a highly effective bisphosphonate, has been shown to reduce spinal fractures by 62% in patients with postmenopausal osteoporosis.6 New analyses from the MOBILE 2-year (Monthly Oral iBandronate In LadiEs) study, presented at the 33rd European Symposium on Calcified Tissues (ECTS), confirm once-monthly Bonviva is highly effective at increasing lumbar spine and hip bone mineral density (BMD), an accepted surrogate for fracture risk reduction.1
Bonviva - a well-tolerated treatment option
Associated side effects are one of the main reasons patients stop taking their osteoporosis treatment.7 MOBILE showed that two years treatment with Bonviva once monthly was not associated with an increased incidence of upper gastrointestinal (GI) adverse events versus the daily dose. In addition, data showed there was no evidence that treatment led to an increased withdrawal due to upper GI adverse events compared to the 2.5mg daily regimen over two-years.2
Patient preference for once monthly dosing
Patient preference is becoming increasingly recognised as an important factor in ensuring treatment is taken for the long term as prescribed. Also presented at ECTS, the results of the BALTO II (Bonviva ALendronate Trial in Osteoporosis) multi-centre clinical study suggest that once-monthly bisphosphonate dosing has the potential to improve adherence, with over 70% of postmenopausal women with osteoporosis* preferring a once-monthly bisphosphonate, finding it more convenient than a once-weekly option.3
BALTO II examined the treatment preferences of 321 women with postmenopausal osteoporosis in centres across the US and Europe and of the 93% who expressed a preference, * 70.6% preferred treatment with Bonviva taken once a month and 76.6% found it more convenient than weekly alendronate. 3 In the study, the most common reason women gave for their preference was that one tablet a month is easier to follow for a long time.3
Helping women to stay on therapy
Also at ECTS, the study design for PERSIST (PERsistence Study of Ibandronate verSus alendronaTe) was presented for the first time. This is a six-month prospective, randomised, open label, multicentre study of over 1,000 women with postmenopausal osteoporosis.8 PERSIST uses a study design that is as close to 'real life' as possible, with patients given prescriptions by their GP and required to visit the local pharmacist to receive the medication, as happens in normal practice.8 The results from the PERSIST trial will show whether patients on a monthly treatment programme stay on treatment longer than those taking a weekly option.
*who had tried both monthly and weekly treatments and who had expressed a preference
About Bonviva
-- Bonviva, a potent and highly effective bisphosphonate, has been studied to date in clinical trials involving over 13,000 patients.
-- Once-monthly Bonviva is indicated for the treatment of osteoporosis in postmenopausal women. It works by reducing elevated bone turnover, increasing bone mineral density and reducing the incidence of vertebral fractures.
-- Bonviva is the only nitrogen containing bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.6
-- Bonviva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, oesophagitis and oesophageal or gastric ulcer.
-- Once-monthly oral Bonviva received European Union approval in September 2005 and Swiss medic approval in August 2005. Once monthly Boniva (the brand name in the US) received FDA approval in March 2005.
Roche/GSK Collaboration
In December 2001, F Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (roche).
About GSK
GSK, one of the world's leading research-based pharmaceutical and healthcare
companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
All trademarks used or mentioned in this release are legally protected.
Roche Healthkiosk, Osteoporosis:
health-kiosk.ch/start_osteo.htm
GSK website:
gsk
References
1. Stone M, Henson J, Stakkesatd JA, Hughes C, Mairon N, et al. Once-monthly ibandronate dosing is more effective than daily dosing for improving bone mineral density: MOBILE 2-year analysis. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.
2. Delmas PD, Stone M, Stakkestad JA, Leigh C, Hiltbrunner V et al. Upper gastrointestinal safety and tolerability profile of once-monthly oral ibandronate: MOBILE 2-year analysis. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.
3. Benhamou C-L, Licata AA, Devas V, Masanauskaite D, Hadji P. Patient preference for once-monthly oral ibandronate and weekly oral alendronate in postmenopausal osteoporosis: the BALTO study. Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.
4. Cowell W, Fulford-Smith A, Poultney S. Adherence with bisphosphonate treatment for osteoporosis in UK patients. Poster presented the second joint meeting of the European Calcified Tissue Society and the International Bone Mineral Society, Geneva, 25-29 June 2005.
5. Cramer J, Amonkar MM, Hebborn A and Suppapanya N. Does dosing regimen impact persistence with bisphosphonate therapy among postmenopausal osteoporotic women? Journal Bone Mineral Research 2004; 19 Suppl 1: S448
6. Chesnut CH, Skag A, Christiansen C, Recker R, Stakkestad JA et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. Journal of Bone & Mineral Research 2004;19(8):1241-49.
7. IPSOS Health, European Survey of Physicians and women with osteoporosis, January-April 2005. Sponsored by Roche/GSK.
8. Cooper, A.L (on behalf of the PERSIST Study Investigators). Rationale and design of the PERSIST study (PERsistence Study of Ibandronate verSus alendronaTe). Abstract presented at 33rd European Symposium of Calcified Tissue, Prague, Czech Republic 10-14 May 2006.
View drug information on Boniva.
вторник, 9 августа 2011 г.
Complimentary Sports Injury Prevention Pamphlet For Women Offered By The Neurologic And Orthopedic Hospital Of Chicago
It's estimated that more than 1.4 million women tear an Anterior Cruciate Ligament (ACL) every year. That's double the number from a decade ago. Responding to a recent increase in sports injuries among female athletes, the Neurologic & Orthopedic Hospital has introduced a new informational pamphlet for female athletes. The pamphlet, entitled "Leveling the Playing Field: Knee Injury Prevention Strategies for Female Athletes," includes tips for reducing an individual's risk of injuries and strengthening exercises for improving balance, coordination, power, strength and speed.
Knee Injury Prevention Pamphlet
Preston Wolin, M.D., director of the Sports Medicine Program at the Neurologic & Orthopedic Hospital of Chicago, believes a general naivety about good strengthening and conditioning practices is a major reason young women are injuring themselves far too frequently in competitive sports.
The knee injury pamphlet makes the following key points:
- One in 10 female collegiate athletes suffer a knee injury each year
- One in 100 female high school athletes suffer a knee injury each year
- Women experience four-to-eight times more knee injuries than men
- Knee injuries are just as common in non-contact sports as in contact sports, due to cutting, planting, pivoting, and changing direction
"These shocking statistics were in part the impetus for offering this brochure as a public service for women who participate in competitive sports," says Dr. Wolin.
Dr. Wolin remarks that women overwork their quadriceps muscles more than men and tend to land more flat-footed as well. This compounds the problem and leads to more knee injuries for women. He advises adding more stretching, strengthening, and sport-specific workouts to an athlete's routine in order to prevent injury. Plyometrics, which are exercises designed to build explosive power, strength, and speed in the legs should be incorporated in order to help facilitate proper jumping technique.
The prevention strategies pamphlet explains why women tend to injure themselves more often, what to do if injury does occur, and what can be done to avoid injury on the playing field. It outlines seven different unique strengthening exercises and shows how to perform them properly. All exercises can be done at home or the gym, making them quite accessible and easy to do.
The pamphlet can be obtained by calling 773-250-1009 or ordering online at neuro-ortho.
The Neurologic & Orthopedic Hospital of Chicago is the country's only freestanding acute care hospital dedicated exclusively to neuroscience and orthopedic services. It utilizes breakthrough technology and minimally invasive techniques as well as advanced procedures for neurosurgery, orthopedics, pain management, neuro-oncology, sports medicine, and rehabilitation. For more information call: 773-250-1000 or visit Neurologic & Orthopedic Hospital online.
Neurologic & Orthopedic Hospital
Knee Injury Prevention Pamphlet
Preston Wolin, M.D., director of the Sports Medicine Program at the Neurologic & Orthopedic Hospital of Chicago, believes a general naivety about good strengthening and conditioning practices is a major reason young women are injuring themselves far too frequently in competitive sports.
The knee injury pamphlet makes the following key points:
- One in 10 female collegiate athletes suffer a knee injury each year
- One in 100 female high school athletes suffer a knee injury each year
- Women experience four-to-eight times more knee injuries than men
- Knee injuries are just as common in non-contact sports as in contact sports, due to cutting, planting, pivoting, and changing direction
"These shocking statistics were in part the impetus for offering this brochure as a public service for women who participate in competitive sports," says Dr. Wolin.
Dr. Wolin remarks that women overwork their quadriceps muscles more than men and tend to land more flat-footed as well. This compounds the problem and leads to more knee injuries for women. He advises adding more stretching, strengthening, and sport-specific workouts to an athlete's routine in order to prevent injury. Plyometrics, which are exercises designed to build explosive power, strength, and speed in the legs should be incorporated in order to help facilitate proper jumping technique.
The prevention strategies pamphlet explains why women tend to injure themselves more often, what to do if injury does occur, and what can be done to avoid injury on the playing field. It outlines seven different unique strengthening exercises and shows how to perform them properly. All exercises can be done at home or the gym, making them quite accessible and easy to do.
The pamphlet can be obtained by calling 773-250-1009 or ordering online at neuro-ortho.
The Neurologic & Orthopedic Hospital of Chicago is the country's only freestanding acute care hospital dedicated exclusively to neuroscience and orthopedic services. It utilizes breakthrough technology and minimally invasive techniques as well as advanced procedures for neurosurgery, orthopedics, pain management, neuro-oncology, sports medicine, and rehabilitation. For more information call: 773-250-1000 or visit Neurologic & Orthopedic Hospital online.
Neurologic & Orthopedic Hospital
суббота, 6 августа 2011 г.
Fighting Frostbite And Cold Weather Injury
With cold weather on the horizon, podiatrists at Temple University's School of Podiatric Medicine warn that people of all ages need to take precautions to protect their feet from cold-related injuries like frostbite, ankle sprains and fractures.
Fighting Frostbite
Prolonged exposure to harsh winter conditions can cause damage to the skin and underlying tissues, or frostbite. During the cold weather months, those who work outdoors and winter sports enthusiasts are particularly vulnerable. Serious cases of frostbite have been known to lead to amputation of a limb or even death. At the very least, the sufferer can experience severe numbness and pain as the area thaws.
"Warm towels and water should be used to warm the affected area at the first sign of numbness. The person should then see a doctor, who can determine if there's any tissue damage," said James B. McGuire, D.P.M., assistant professor of podiatric medicine.
Poor circulation can also lead to frostbite. The elderly, smokers, caffeine drinkers and people with illnesses characterized by poor circulation, such as diabetes, hypothyroidism and arteriosclerosis (hardening of the arteries), are all prone to this type of injury. Alcohol and the use of certain drugs or medications may also put a person at risk by hindering his or her ability to recognize the warning signs.
"Dressing properly is the best defense against the problems that severe weather causes," said McGuire. "But it is important to remember that proper foot gear is just as important as a warm coat, hat and gloves."
Because extreme cold and wet clothes put exposed areas such as the feet and toes in jeopardy, well-insulated shoes and boots are a must, McGuire stressed. And socks made from acrylic keep feet dry by slicking away perspiration from inside shoes and boots.
Cold Weather Injuries
Winter athletes should check their boots and shoes on a yearly basis to ensure proper fit. Too-tight or loose footwear can cause blisters and abrasions, impair control and lead to accidents.
"For skiers, high speeds and gravity pressure raise the probability of injuring the lower extremities. Ice skating and hockey pose added risk to the ankle region during quick turns and stops," said McGuire.
But serious wintertime injuries are not problems solely for athletes.
"Ankle sprains and ankle fractures are much more prevalent this time of year for everyone. Ice and snow create the impetus for injury by allowing the foot to twist on the leg in such a way that ligaments and bone are damaged," said Howard Palamarchuk., assistant professor of podiatric surgery.
According to Palamarchuk, initial treatment for these injuries should include rest, ice, immobilization, compressive wraps and elevation (commonly known as RIICE). He advises that any ankle or foot injury with pain and swelling beyond 48 hours be checked out by a podiatric physician.
Source:
Temple University
Fighting Frostbite
Prolonged exposure to harsh winter conditions can cause damage to the skin and underlying tissues, or frostbite. During the cold weather months, those who work outdoors and winter sports enthusiasts are particularly vulnerable. Serious cases of frostbite have been known to lead to amputation of a limb or even death. At the very least, the sufferer can experience severe numbness and pain as the area thaws.
"Warm towels and water should be used to warm the affected area at the first sign of numbness. The person should then see a doctor, who can determine if there's any tissue damage," said James B. McGuire, D.P.M., assistant professor of podiatric medicine.
Poor circulation can also lead to frostbite. The elderly, smokers, caffeine drinkers and people with illnesses characterized by poor circulation, such as diabetes, hypothyroidism and arteriosclerosis (hardening of the arteries), are all prone to this type of injury. Alcohol and the use of certain drugs or medications may also put a person at risk by hindering his or her ability to recognize the warning signs.
"Dressing properly is the best defense against the problems that severe weather causes," said McGuire. "But it is important to remember that proper foot gear is just as important as a warm coat, hat and gloves."
Because extreme cold and wet clothes put exposed areas such as the feet and toes in jeopardy, well-insulated shoes and boots are a must, McGuire stressed. And socks made from acrylic keep feet dry by slicking away perspiration from inside shoes and boots.
Cold Weather Injuries
Winter athletes should check their boots and shoes on a yearly basis to ensure proper fit. Too-tight or loose footwear can cause blisters and abrasions, impair control and lead to accidents.
"For skiers, high speeds and gravity pressure raise the probability of injuring the lower extremities. Ice skating and hockey pose added risk to the ankle region during quick turns and stops," said McGuire.
But serious wintertime injuries are not problems solely for athletes.
"Ankle sprains and ankle fractures are much more prevalent this time of year for everyone. Ice and snow create the impetus for injury by allowing the foot to twist on the leg in such a way that ligaments and bone are damaged," said Howard Palamarchuk., assistant professor of podiatric surgery.
According to Palamarchuk, initial treatment for these injuries should include rest, ice, immobilization, compressive wraps and elevation (commonly known as RIICE). He advises that any ankle or foot injury with pain and swelling beyond 48 hours be checked out by a podiatric physician.
Source:
Temple University
среда, 3 августа 2011 г.
Bone Medical Receives Positive FDA Feedback On CaPTHymone™
Bone Medical Limited (ASX: BNE) announced that it has had discussions with FDA on the US regulatory process for CaPTHymone™, Bone's oral Parathoid Hormone product.
Bone's Chairman, Leif Helth Jensen said "We are very pleased with the outcome of our discussions as we have largely had our plans for product development and regulatory strategy for CaPTHymone™ confirmed."
"Our next clinical step is to enter a Phase IIb study where the primary clinical end point will be lumbar spine Bone Mineral Density (BMD) and the secondary end point will be the bio maker P1NP. This study is likely to take 6 months and involved an estimated 150 patients.'
"Assuming this trial meets its clinical endpoint, the next step will be a pivotal Phase III non-inferiority study of 12 months duration, involving an estimated 400 patients, which will be sufficient for registration purposes under rule 505(b)(2)." continued Leif Helth Jensen.
The FDA also wants Bone to document that CaPTHymone™'s pharmacokinetics are similar to that of Forte's (Lilly's injectable PTH product), a benchmark Bone is comfortable it can meet.
Bone's Chief Scientific Officer, Dr Roger New said "For the first time Bone now knows exactly what the FDA will need documented. Based on previous clinical work carried out with CaPTHymone™ we are confident that we will be able to meet these requirements. We are also pleased that the FDA has recognised the product development and regulatory strategy which Bone initiated 2-3 years ago. The challenges set by the FDA for CaPTHymone™, in comparison with new chemical entity drugs, are in general less expensive, and with the right level of funding be finalised over the next few years."
About Bone Medical Limited
Bone Medical Limited is an international biopharmaceutical development company positioned to exploit the growing market in the treatment of bone disease particularly in osteoporosis and arthritis. Bone has a portfolio of biopharmaceutical development projects for the treatment of bone disease including,
Osteoporosis
-- Capsitonin™ oral calcitonin
-- CaPTHymone™ oral parathyroid hormone
-- bone cell regulators BN005 & BN008
Arthritis
-- TNF regulators BN006
-- joint protection & collagen tolerance BN007
Bone Medical Limited
Bone's Chairman, Leif Helth Jensen said "We are very pleased with the outcome of our discussions as we have largely had our plans for product development and regulatory strategy for CaPTHymone™ confirmed."
"Our next clinical step is to enter a Phase IIb study where the primary clinical end point will be lumbar spine Bone Mineral Density (BMD) and the secondary end point will be the bio maker P1NP. This study is likely to take 6 months and involved an estimated 150 patients.'
"Assuming this trial meets its clinical endpoint, the next step will be a pivotal Phase III non-inferiority study of 12 months duration, involving an estimated 400 patients, which will be sufficient for registration purposes under rule 505(b)(2)." continued Leif Helth Jensen.
The FDA also wants Bone to document that CaPTHymone™'s pharmacokinetics are similar to that of Forte's (Lilly's injectable PTH product), a benchmark Bone is comfortable it can meet.
Bone's Chief Scientific Officer, Dr Roger New said "For the first time Bone now knows exactly what the FDA will need documented. Based on previous clinical work carried out with CaPTHymone™ we are confident that we will be able to meet these requirements. We are also pleased that the FDA has recognised the product development and regulatory strategy which Bone initiated 2-3 years ago. The challenges set by the FDA for CaPTHymone™, in comparison with new chemical entity drugs, are in general less expensive, and with the right level of funding be finalised over the next few years."
About Bone Medical Limited
Bone Medical Limited is an international biopharmaceutical development company positioned to exploit the growing market in the treatment of bone disease particularly in osteoporosis and arthritis. Bone has a portfolio of biopharmaceutical development projects for the treatment of bone disease including,
Osteoporosis
-- Capsitonin™ oral calcitonin
-- CaPTHymone™ oral parathyroid hormone
-- bone cell regulators BN005 & BN008
Arthritis
-- TNF regulators BN006
-- joint protection & collagen tolerance BN007
Bone Medical Limited
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