Posts Tagged ‘Pain’

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Algorithms improve certainty in ruling out deep and pelvic vein thrombosis at primary level of patient care

Algorithms improve certainty in ruling out deep and pelvic vein thrombosis at primary level of patient care

Algorithms improve certainty in ruling out deep and pelvic vein thrombosis at the primary level of patient care, say Lobna El Tabei and her co-authors in the current issue of the Deutsches Ärzteblatt International.

Deep vein thrombosis (DVT) can lead to fatal pulmonary embolism or chronic post-thrombotic syndrome. To improve differential diagnostic certainty, scores have been developed that allow the clinical probability of DVT to be calculated on the basis of weighted combinations of individual clinical findings. Items of these scores are, for example, cancer, paresis of the leg, extended periods of bed rest, swelling, and pain.

The primary aim of the study was to determine diagnostic accuracy regarding exclusion of DVT using a treatment algorithm consisting of one of these scores, the Wells score, followed by either a D-dimer test and/or compression sonography—depending on the result of the Wells score—and to compare this with the diagnostic accuracy of the primary care physician’s clinical judgment alone.

The algorithm investigated by the authors allows the primary care physician to rule out DVT with a high degree of probability. In this study, which included 395 patients, only 1% of cases of DVT were missed, compared with 5% when relying on clinical judgment alone.

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Novel electrotherapy reduces energy needed to re-establish normal rhythm in the heart

Novel electrotherapy reduces energy needed to re-establish normal rhythm in the heart

Implantable defibrillators currently on the market apply between 600 and 900 volts to the heart, almost 10 times the voltage from an electric outlet, says Ajit H. Janardhan, MD, PhD, a cardiac electrophysiology fellow at the Washington University’s School of Medicine.

After being shocked, he says, some patients get post-traumatic stress disorder. Patients may even go so far as to ask their physicians to remove the defibrillator, even though they understand that the device has saved their lives.

The huge shocks are not only unbearably painful, they damage the heart muscle and have been shown in many studies to be associated with increased mortality. In an advance online edition of the Journal of American College of Cardiology, Janardhan and Igor Efimov, PhD, professor of biomedical engineering in the School of Engineering & Applied Science, report on a low-energy defibrillation scheme that significantly reduces the energy needed to re-establish a normal rhythm in the heart’s main chambers.

They hope this electrotherapy will be much less painful than shocks from existing implantable defibrillators, and may even fall beneath the threshold at which patients begin to perceive pain.

The team has just received a National Institutes of Health grant to develop a prototype low-energy defibrillator for humans and plan to begin clinical trials of the device shortly.

Losing the beat

The lub-dub of the heartbeat begins with an electrical impulse generated by the sinoatrial node, a group of cells on the wall of the right atrium that is the heart’s natural pacemaker.

Spreading through conductive pathways in the heart, the electrical signal first causes the two upper chambers of the heart (the atria) to contract, and then, a split second later, the two lower chambers (the ventricles), coordinated motions that efficiently pump blood to the rest of the body.

The synchronized squeezing of a normal heartbeat is called sinus rhythm, after the node that triggers it.

The rhythm can go wrong in many different ways, but the real killer is ventricular tachycardia. Ventricular tachycardia is an abnormal heart rhythm that starts in the ventricles rather than from the sinoatrial node, and that causes the heart to beat at a rate too fast (tachy is Greek for rapid or fast) to efficiently pump blood to the rest of the body.

Moreover, the rapid heartbeat can degenerate precipitously into ventricular fibrillation, or the loss of all rhythm, says Efimov. During ventricular fibrillation the uncoordinated contraction of heart muscle prevents the heart from pumping blood at all, and without immediate intervention, death quickly follows.

Most people who develop ventricular tachycardia and ventricular fibrillation outside the hospital die, says Janardhan, but studies show that if we implant a defibrillator in patients with a weak heart that does not pump as strongly as it should, we can significantly reduce mortality.

Restarting the rhythm

There are really only three therapies for ventricular tachycardia, Efimov says. One is drugs that reduce the likelihood of tachycardia, but drugs are often ineffective.

The second is ablation, or the deliberate creation of nonconductive scar tissue within the heart that blocks abnormal conductive patterns and redirects electrical activity to more normal pathways.

The major problem with ablation, says Efimov, is recurrence. It’s a temporary measure, not a cure. Patients typically need additional treatment within five years.

The third therapy is an implantable cardioverter defibrillator, or ICD. These devices are placed beneath the skin in the chest and monitor the rate and rhythm of the heart. If they detect ventricular tachycardia, they try to break the rhythm by pacing the heart at a rate faster than its intrinsic rate, a strategy anti-tachycardia pacing.

Anti-tachycardia pacing is very low energy, so low that patients may not even sense it. But it is relatively ineffective when the heart is beating 200 time per minute or faster. At these higher rates, the ICS zaps the heart with a strong electrical shock that resets it and, with luck, allows the pacemaker node to restart it with a normal rhythm.

A novel electrotherapy

The scientists knew from earlier experiments that the voltage needed to shut down ventricular tachycardia depended on the timing of the shock. This led them to ask whether a sequence of multiple, closely timed low-voltage shocks might be more effective than a single high-voltage shock, and be less sensitive to timing.

Indeed it turned out that if they shocked the heart multiple times they could reduce the peak shock amplitude from well over 200 volts to 20 volts, timing no longer mattered, and the therapy worked even if the ventricular tachycardia was very rapid.

Although this electrotherapy involves multiple shocks, the total energy it delivers is still lower than that of a single large shock, roughly 80 times lower.

Why do multiple shocks work better? Arrhythmias generate electrical wave vortices – little electrical tornadoes in the heart – and it is these vortices, or re-entrant circuits, that make the heart beat too fast and prevent it from pumping properly.

But immediately after it contracts, heart muscle goes through a refractory, or unresponsive, period during which it does not respond to electrical stimulation. The multiple shocks may do a better job of extinguishing the re-entrant circuits by creating an area of unresponsive muscle into which the re-entrant wavefront -the electrical tornado – crashes, the scientists suggest.

Relocating the Electrodes

Defibrillators now on the market apply shocks between the right ventricle (RV) and an “active can” located above the chest wall, below the collarbone. The shocks are painful in part because they pass through the chest wall muscle and sensory nerves.

The investigators found they could reduce peak shock voltages by an additional 50 percent if they applied shocks between the RV and coronary sinus (CS), a vessel that collects deoxygenated blood from the heart muscle, rather than through the chest wall. Less energy was required because the shocks were confined to the heart itself, and for the same reason they were also less painful.

In an earlier paper, Efimov’s student Wenwen Li, PhD, now at St. Jude Medical, had reported on a similar strategy for restoring the rhythm of the atria, the two upper chambers of the heart, for a less serious but more common rhythm abnormality.

The team has already developed the first low-energy atrial defibrillator, which will soon be entering clinical trials. They hope for similarly rapid progress with the ventricular defibrillator.

“We think this technology can and will be implemented soon,” says Janardhan. “There’s a lot of cardiac research that may pan out 20 or 30 years from now,” he says, “but as a physician I want something that can help my patients now.”

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AspenBio Pharma provides clinical and business update for third quarter 2012

AspenBio Pharma provides clinical and business update for third quarter 2012

AspenBio Pharma, Inc. (Nasdaq: APPY), an in vitro diagnostic company, today provided a clinical and business update for the third quarter 2012. The Company reported it has started the hospital training phase of its pivotal U.S. clinical study and remains on track to initiate patient enrollment before the end of the year. AspenBio also reiterated its anticipated timeline for obtaining CE Mark for its lead blood-based diagnostic test by year end, and provided an update on market development activities in Europe, including its discussions with potential commercial distributors.

Steve Lundy, Chief Executive Officer of AspenBio Pharma, commented, “We’re happy with the progress made since our last update. We updated our clinical trial protocol for the pivotal study, incorporating the FDA’s feedback from our September meeting, and have begun training our hospital sites, preparing them to begin enrolling patients. This is a key development for AspenBio, because it sets the foundation for a clinically successful trial and brings us closer to potential FDA clearance and commercialization of our in vitro diagnostic test in the United States. In parallel, we’ve advanced our negotiations significantly with European distributors in key commercial territories, engaged an experienced Europe-based sales and marketing consultant, and continued to scale up our product manufacturing activities in order to maximize our potential for a timely and successful European product launch after obtaining CE Mark.”

AspenBio expects to continue training the remaining hospital sites on the trial protocol over the coming weeks in order to advance to patient enrollment before the end of the year. Once enrollment commences, the study is expected to enroll a total of ~2,000 net evaluable patients at approximately 25 hospital emergency departments across the United States. AspenBio plans to complete this study, file for marketing clearance, and upon receipt of such clearance from the FDA, launch the product in the U.S. in late 2013.

In Europe, the Company is currently pursuing agreements with top distributors in what AspenBio believes will be major sales territories, including Germany, UK, France, Italy and Benelux. The Company expects to file for and obtain CE Mark for its diagnostic test before the end of the year and hopes to be positioned to commence sales and distribution efforts as soon as possible thereafter.

At September 30, 2012, the Company had $10.2 million in cash, cash equivalents and short-term investments. AspenBio believes it has sufficient cash to complete the planned pivotal trial, as well as launch the product in Europe.

Mr. Lundy concluded, “This is a critical time in the Company’s history, with many exciting regulatory, development and commercial initiatives ongoing. We remain deeply focused on execution of these important milestones, and we look forward to providing additional near-term updates as we advance toward commercialization of our first diagnostic product.”

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Study finds several osteoporosis risk factors among post-menopausal women on HRT

Study finds several osteoporosis risk factors among post-menopausal women on HRT

A preliminary study of 127 post-menopausal women on hormone replacement therapy in Portugal suggests that there are several risk factors associated with osteoporosis and bone fracture these include age, low bone mineral density, a sedentary lifestyle, coffee consumption and ovariectomy. Details are reported later this month in the International Journal of Medical Engineering and Informatics.

Osteoporosis is a disease of the skeleton commonly associated with low bone mass and is predominant in elderly, post-menopausal women. Elza Fonseca of the Polytechnic Institute of Bragança and colleagues there and at the Medical Imaging Centre in Porto, point out that osteoporosis was common in the group of Portuguese women studied. They discuss data from different geographic regions concerning this public health problem.

The team hoped to identify common factors and so underpin knowledge on this potentially debilitating and critical bone disease. The clinical relevance is that those with the condition are highly susceptible to bone fractures, which can lead to pain, hospitalisation and disablement, particularly in the case of hip, spine and wrist fracture. Indeed, fractures linked to osteoporosis are unfortunately often linked to patient death.

Bone mass density as determined by dual energy X-ray absorptiometry (DEXA) has been used frequently to determine whether a particular patient is at increased risk of fracture, it also provides a quantitative marker for osteoporosis, which is defined as having BMD 2.5 standard deviations below average. Osteopenia, a precursor condition to osteoporosis, is marked by a BMD 1.0 to 2.5 below average.

The researchers point out that, controversy exists among experts regarding the value of BMD as a diagnostic criterion for osteoporosis. They explain that there is good evidence to support the cost-effectiveness and efficacy of early prescription of preventive drugs, but it is not clear at which point below the threshold this should be. Their new study on lifestyle and other risk factors should couple neatly with such discussions and allow more informed decisions to be made regarding the use of drugs in patients with signs of osteopenia who may, or may not, go on to develop osteoporosis.

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BeamPath ROBOTIC system from OmniGuide used in Laparoscopic Myomectomy

BeamPath ROBOTIC system from OmniGuide used in Laparoscopic Myomectomy

Antonio R. Gargiulo, MD of the Center for Infertility and Reproductive Surgery at Brigham and Women’s Hospital completed a live surgery for the American Society of Reproductive Medicine (ASRM), treating a patient suffering from uterine fibroids with a novel robotic surgical approach and a cutting edge laser technology developed at OmniGuide® in Cambridge, MA.

“This live telesurgery was a wonderful opportunity to share the excellent work we are doing at Brigham and Women’s in treating a prevalent and painful disease state”

Dr. Gargiulo and his team performed the surgery – a Robot-Assisted Laparoscopic Myomectomy -at Brigham and Women’s Faulkner Hospital, broadcasting the live video feed to an international audience of over 1,000 reproductive specialists attending the 68th annual ASRM meeting in San Diego, CA.

“This live telesurgery was a wonderful opportunity to share the excellent work we are doing at Brigham and Women’s in treating a prevalent and painful disease state,” noted Dr. Gargiulo, who also serves as the Medical Director of the Center for Robotic Surgery at Brigham and Women’s Health Care and as an Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School.

Fibroids (the lay term for uterine leiomyomata) are non-cancerous tumors of the uterus affecting a large number of women, with the National Institutes of Health estimating that more than 70% of women will develop fibroids by the time they reach 50 years of age. Dr. Gargiulo continued, “Patients suffering from uterine fibroids in our practice present with abnormal uterine bleeding, pelvic pain, infertility or recurrent pregnancy loss. By means of conservative surgery (removal of the tumors and reconstruction of the uterus) patients can look forward to a resolution of their symptoms and/or to successfully conceive and have a normal pregnancy. I believe that sharing the specific details of our novel surgical approach with the members of the ASRM will lead to more options and better outcomes for these patients across the country.”

The surgical technique demonstrated during the live broadcast was a minimally invasive, robot-assisted approach to access the uterus for treatment. Dr. Gargiulo then employed a flexible carbon dioxide laser system to very precisely perform uterine incisions to remove fibroids that were in close association with essential reproductive structures (uterine lining and tubes). Delivering this advanced laser energy was the BeamPath® ROBOTIC system from OmniGuide, which employs a proprietary technology to couple the precision of CO2 laser with the platform of robotic surgery.

Describing his approach, Dr. Gargiulo concluded, “The flexible CO2 laser combined with the three-dimensional view and the intuitive instrument manipulation allowed by the surgical robot provides the surgeon with a true minimally-invasive microsurgical platform for treating patients with uterine fibroids (as well as other reproductive conditions). As an alternative to other devices that transmit energy beyond your incision, this flexible CO2 laser technology provides a level of precision that will change the way we treat our patients in reproductive medicine. I am pleased to offer it to my patients and share my experience with the ASRM.”

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First study to measure minute changes in breast tumor connective tissue fibers

First study to measure minute changes in breast tumor connective tissue fibers

Using advanced microscopes equipped with tissue-penetrating laser light, cancer imaging experts at Johns Hopkins have developed a promising, new way to accurately analyze the distinctive patterns of ultra-thin collagen fibers in breast tumor tissue samples and to help tell if the cancer has spread.

The Johns Hopkins researchers say their crisscrossing optical images, made by shining a laser back and forth across a biopsied tissue sample a few millionths of a meter thick, can potentially be used with other tests to more accurately determine the need for lymph node biopsy and removal in women at risk of metastatic breast cancer.

In what is believed to be the first study to measure minute changes in tumor connective tissue fibers, researchers found that eight women whose cancers had spread beyond the breast through the body’s lymphatic system had about 10 percent more densely packed and radially spread-out collagenous structural proteins than six women whose cancers had not yet spread. Collagen fibers in the non-metastasized tumors, also obtained during breast biopsy, were more diffuse and arranged in a transverse or horizontal pattern. All 14 women in the study had aggressive, malignant breast cancer.

In the new report, to be published in the Journal of Biomedical Optics online Nov. 1, researchers say that if these “proof of principle” findings hold up in testing now under way in hundreds more women with or without metastatic breast cancer, then their new optical imaging tool could simplify testing for spreading disease and help people avoid unnecessary lymph node surgery.

“Our new diagnostic technique has the potential to help reassure thousands of breast cancer patients that their cancers have not spread to other organs, and could help them avoid the risks and pain currently involved in direct inspections of lymph nodes for the presence of cancerous cells,” says study senior investigator Kristine Glunde, Ph.D.

Women with denser tumor fiber patterns would likely stand a greater chance of needing lymph node biopsy and removal and inspection of such tissue for malignant cells, says Glunde, an associate professor at the Johns Hopkins University School of Medicine Russell H. Morgan Department of Radiology and the Sidney Kimmel Comprehensive Cancer Center.

Glunde says complications from lymph node biopsy and more invasive dissection include risk of infection, pain, severe swelling and leakage of lymph fluid around the armpit, as well as stiffening in the arm, which can be permanent. An estimated 230,000 Americans were diagnosed in 2011 with invasive breast cancer, while another 57,000 were found to have noninvasive, or in-situ breast cancer.

Cancer imaging experts have known for more than a decade that the fibrous connective tissue located between cancer cells changes and bunches together as tumors grow and disease spreads, says study co-investigator Zaver Bhujwalla, Ph.D., a professor at Johns Hopkins and its Kimmel Cancer Center.

“Until now, however, we had no proof in principle that such minute and progressive changes outside cancer cells, in the tumor micro-environment or extracellular matrix, could be measured and potentially used to better guide our staging and treatment decisions,” says Bhujwalla, who also serves as director of the Johns Hopkins In Vivo Cellular and Molecular Imaging Center (ICMIC), where the latest imaging study was performed.

It was also at ICMIC in 2010, supported with funds from the U.S. National Cancer Institute (NCI), that Glunde, Bhujwalla and fellow study co-investigator Meiyappan Solaiyappan, B.S., developed the specialized computer software used to analyze the microscopic spaces between tumor collagen fibers and calculate their density.

The tissue fiber images were obtained using an optical imaging technique called second harmonic generation microscopy, in which a long-wavelength laser light is deflected off the collagen fibers for a few seconds, allowing for several planes and fields of view to be captured. The longer infrared wavelength, at 880 micrometers, was chosen because it can penetrate the tissue beyond the colorful light waves visible to the human eye, but does not damage and heat up the cancer cells, as a slightly longer infrared wavelength would. Glunde says the many fields of view were randomly taken throughout the tissue sample, providing a “realistic representation of each breast cancer sample.” Breast biopsy samples came from tissue research collections in Maryland.

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Bypass surgery offers people with diabetes better long-term survival than stents

Bypass surgery offers people with diabetes better long-term survival than stents

People with diabetes mellitus who undergo heart bypass surgery for multiple blocked arteries have a significantly better 5-year-survival rate than diabetic patients who undergo angioplasty with drug-eluting stents (DES), according to a study published in the November 2012 issue of The Annals of Thoracic Surgery.

Key Points

Bypass surgery offers people with diabetes better long-term survival than stents.

People with diabetes who receive stents, even drug eluting stents, are more likely to have recurrent chest pain, require reintervention, and suffer non-fatal heart attacks.

Cardiothoracic surgeons and cardiologists can work together to help people with diabetes determine the best procedure for them.

The study, by researchers at Israel’s Tel Aviv Sourasky Medical Center, is the first comparative effectiveness demonstration of coronary artery bypass grafting (CABG) surgery using both internal thoracic arteries versus percutaneous coronary intervention (PCI) with DES in patients with diabetes.

Yaron Moshkovitz, MD, Rephael Mohr, MD, and colleagues reviewed 5-year outcomes for 226 patients who underwent bilateral internal thoracic artery (BITA) grafting with outcomes for 271 patients who underwent PCI with DES. They found that BITA patients had a 13% greater survival rate, as well as a lower risk for non-fatal heart attacks, recurrent chest pain, and future re-interventions. Additionally, they found that the more stents that were used, the greater the risk of a major cardiovascular event.

“The long-term benefit of BITA bypass graft surgery is probably related to the protection provided by CABG conduits that bypass the blockages and protect against future blockages,” said Dr. Mohr. “Protection from recurrent coronary events due to disease progression cannot be achieved by the stents placed in the coronary arteries during heart catheterization.”

People with diabetes mellitus, a disease that affects an estimated 14.5 million Americans, are at higher risk for death from coronary artery disease (CAD) and face increased risks from procedures to treat CAD, according to the National Heart, Lung, and Blood Institute. These risks include kidney failure, stroke, and infection.

CAD in diabetic patients is more diffuse and progresses faster than CAD in people who do not have diabetes. Dr. Mohr explained that coronary arterial blood vessels in diabetic patients are smaller, which increase the risk of new blockages of the blood vessels after treatment with stents.

“We recommend the surgical option to our patients with diabetes and significant coronary artery disease because bypass will promise them longer survival with a lower chance for return of angina or additional procedures to address blockage,” said Dr. Mohr. “They will also have a reduced chance of heart attack and cardiac-related mortality.”

Future of CAD Treatment for Patients with Diabetes

Peter K. Smith, MD, Division Chief of Cardiovascular and Thoracic Surgery at Duke University Medicine in Durham, NC, said awareness of this study is very important.

“This study indicates that, in general, bypass surgery is preferred for patients with diabetes,” said Dr. Smith, who was not involved with the research. “The durability of bypass grafts compared to DES is especially important because diabetic patients more frequently have all of their coronary arteries blocked, the disease in the arteries is more serious in nature, and they frequently have had a heart attack in the past.”

Dr. Mohr said he hopes his research will encourage surgeons to make more considerable use of arterial grafts, especially of the internal thoracic arteries, in diabetic patients. “It is also possible that this paper will influence the interventional cardiologists to discontinue implantation of stents in diabetic patients with a blockage of more than one heart vessel,” he said.

Dr. Smith advocates a heart team approach, where surgeons and cardiologists work together to recommend treatment for their patients. “Patients with diabetes should have the benefit of this type of multidisciplinary consideration,” he noted. “Patients with diabetes should be aware of their choices, and if bypass surgery is not recommended, they should ask why.”

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Diffusion tensor imaging detects complex muscle structures in 3D

Diffusion tensor imaging detects complex muscle structures in 3D

Eindhoven University of Technology (TU/e) and the Academic Medical Center (AMC) in Amsterdam have together developed a technique that allows detailed 3D imaging of complex muscle structures of patients. It also allows muscle damage to be detected very precisely. This new technique opens the way to much better and more patient-friendly diagnosis of muscular diseases. It also allows accurate, non-invasive muscle examinations among top athletes. Martijn Froeling received a PhD for this research at TU/e on Monday 29 October.

Froeling uses diffusion tensor imaging (DTI), an MRI technique that allows the movements of water molecules in living tissue to be viewed. Because muscles are made of fibers, the movements of water molecules in the direction of the fibers are different from those in other directions. This characteristic allows muscles to be imaged with a high level of detail. This was already possible on a small scale with simple muscles, but thanks to Froeling’s work it can now also be done on a larger scale and with complex muscle structures. More importantly, this improved technique also reveals very small muscle damage, because of the different movements of the water molecules in damaged muscle fibers.

3D images

To reach these results, Froeling improved the data acquisition process – the way the MRI scanner images the muscle under examination. This has to be performed relatively quickly, because it is uncomfortable for patients to lie in an MRI scanner for a long time, but at the same time it has to provide sufficiently detailed data. He also improved the processing of the acquired data into reliable 3D images. Physicians can now easily view complex muscle structures from all angles on-screen. No new equipment was needed; the researchers used standard widely available clinical systems.

Marathon runners

As a practical study, Froeling imaged a range of subjects including the thighs of marathon runners at different times: one week before a marathon, two days after it, and again three weeks after. He was able to visualize the muscle damage following the marathon. This was still visible after three weeks, even though the runners themselves in many cases no longer reported any pain in their muscles. Another study was of the pelvic floor in women; a good example of a highly complex muscle structure. The technique has proved to be capable of imaging this structure with great accuracy, which makes it potentially very valuable for the diagnosis of conditions such as uterine prolapse.

Wide application area

AMC Amsterdam and TU/e now intend to use this technique in studies of post polio syndrome and spinal muscular atrophy. Froeling believes there are numerous potential applications: there are around 600 different types of muscle disease and damage, and the new technique will improve the ability to study these. However further studies will first be needed: although the technique allows muscle disease or injury to be imaged it does not reveal the precise cause, which may be tearing, fat infiltration or other abnormalities. Clarification is also still needed on what are the normal values for healthy men and women of different ages, to provide a reference framework for identifying abnormalities in different groups of patients. Another kind of application is in examinations of top athletes, to allow timely detection of muscle damage or better estimation of the recovery time needed after injuries.

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FDA Approves Clinical Trial for DIAM Spinal Stabilization System

FDA Approves Clinical Trial for DIAM Spinal Stabilization System

FDA Approves Clinical Trial for DIAM Spinal Stabilization System

Medtronic Inc. announced that it has received an investigational device exemption for its DIAM™ Spinal Stabilization System for use in a clinical study. This allows Medtronic to begin the first of three clinical trials in the US and Europe. The DIAM System was developed to reduce pain in degenerative stenosis patients who predominantly suffer from “radiating leg discomfort and moderate low back pain and is the only non-rigid interspinous spacer under clinical investigation.”

Here’s more about the study and the device:

The initial Medtronic study will examine the safety and effectiveness of the DIAM System when used to treat patients with degenerative stenosis. Degenerative stenosis is a common condition in the aging process, marked by the gradual narrowing of the spinal canal, resulting in pressure on the spinal cord or nerve roots.

Degenerative stenosis affects more than 250,000 U.S. patients each year. Stenotic spine patients with radiating leg pain or numbness typically undergo decompression surgery alone. Patients with both leg and back pain normally have a decompression surgery with fusion. The purpose of decompression surgery is to release excess pressure by creating more space in the spinal canal. Combined with decompression, the DIAM System could offer patients with leg and back pain a minimally invasive alternative to spinal fusion.

The implant is placed between the spinous processes (the visible ridges of the back) to act as a shock absorber that reduces loads on the surrounding vertebrae and restores the natural function of the joint. 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.

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DSM extends license to supply CarboSil® TSPCU for use in AxioMed Spine Corporation’s Freedom® Spinal Discs

DSM extends license to supply CarboSil® TSPCU for use in AxioMed Spine Corporation’s Freedom® Spinal Discs

DSM, a global leader in biomedical materials sciences, and AxioMed Spine Corporation, an innovator in the field of spinal implant devices, today announced that they have revised and extended an existing licensing and supply agreement. DSM will supply its proprietary CarboSil®Thermoplastic Silicone-Polycarbonate-urethane material for use in AxioMed’s Freedom® Lumbar and Freedom® Cervical Discs.

Symptomatic degenerative disc disease is one of the most common causes of low back pain and occurs when the intervertebral discs in the spine degenerate and lose flexibility, elasticity and shock absorbing characteristics. Treatment options include spinal fusion and total disc replacements (TDRs), the use of which have grown rapidly in part due to the increasing sophistication of the devices used in the procedures. In the United States, for example, more than 570 thousand spinal fusion procedures were performed in 2011, a 4.9% increase over 2010, according to the Millennium Research Group. Growth in TDR procedures has been even more dramatic, with nearly 20 thousand procedures performed in 2011, which represents an 11.9% increase over 2010 numbers. Spinal fusion joins two or more vertebrae together, immobilizing the faulty vertebrae and eliminating pain caused by abnormal motion. TDRs are designed to replace degenerated discs and allow motion in faulty vertebrae, which can lead to diminished disability and faster recovery times. TDRs also prevent the premature breakdown of discs in adjacent levels of the spine, a potential risk in fusion surgeries.

The first generations of TDRs were a ball and socket design using metal on metal materials. As the implants evolved, new materials were incorporated into their design including polymers. DSM’s CarboSil® TSPCU is an advanced copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes. The material can improve in vitro and in vivo stability and helps prevent oxidative degradation, which can lead to improved patient results and longer lasting implants. The load bearing qualities of CarboSil® TSPCU help secure the total disc replacement device in place as it flexes with the natural movement of the spine. DSM’s novel materials designed specifically for the spinal market are incorporated in three TDR devices, as well as eleven dynamic stabilization applications with additional applications in development

“Spinal fusion has been the standard of care for degenerative disc treatment, but recently payer groups and insurance companies have begun lowering reimbursements for fusion procedures and questioning its cost and applications to certain patient groups,” said William Fuller, Director of BusinessDevelopment, Orthopedics at DSM Biomedical. “This creates an opportunity to highlight the benefits of total disc replacements and DSM material technology as AxioMed’s Freedom® Lumbar Disc undergoes clinical trials in the United States.”

AxioMed first introduced the Freedom® Lumbar Disc and the Freedom® Cervical Disc in Europe and received CE Mark approvals in May 2009 and May 2012, respectively, which proved instrumental in the Freedom® Lumbar Disc device becoming the first elastomeric disc to receive an Investigational Device Exemption (IDE) from the U.S. FDA. The disc is currently under evaluation in an ongoing multi-center U.S. and EU IDE pivotal clinical study designed with efficacy, safety and economic endpoints.

“The viscoelastic material properties of CarboSil® TSPCU and proven track record of DSM’s technology are ideal for our spinal discs,” said Patrick McBrayer, AxioMed’s President and CEO. “Our aim is to provide patients with pain relief, reduced disability and improved lifestyle by combining our companies’ innovations.”

DSM – Bright Science. Brighter Living.™

Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences, DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext. More information can be found at

About AxioMed Spine Corporation

AxioMed’s mission is to develop products focused on spinal function for patients with degenerative spine disease, thus advancing the standard of care beyond fusion and first generation discs. The Freedom® Lumbar and CervicalDiscs have been developed and designed by a team of clinicians and experts in the fields of biomechanics, pathology, spinal surgery and polymer science. Focusing on restoration of the natural function of the spine, AxioMed will enhance human health through research, innovation, development and service world-wide. For more information about AxioMed, please visit our web site at

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