Biocompatibility tests have long been part of medical device development. But these days, regulators expect that device companies will also test their materials in order to chemically characterize them. This is in part because the latest version of ISO 10993 calls for chemical characterization and, in Part 18, suggests ways to do it, says a materials expert. "Adverse events caused by materials are generally chemical and produced by mechanical components, contaminants, or breakdown products that cause a biological effect in the body," said David E. Albert, PhD, senior scientist and chief chemist for NAMSA. "Chemicals cause the reactions that we're testing for." Albert spoke recently at the MD...
February 11th, 2008
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The most important thing for a device firm to consider when designing a documentation management system is not the requirements of regulators, but the needs of the company, says a consultant. "Usability is first, regulatory is secondary," said Susan C. Reilly of Reilly...
February 11th, 2008
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Medrad Inc., a Bayer affiliate that makes imaging systems, announced it will acquire Possis Medical, Inc., which makes mechanical thrombectomy devices, for about $361 million. While on the surface the firms appear to be very different, what they have in common is a focus on cardiovascular intervention. Medrad is best known for contrast injection systems that are used to diagnose cardiovascular diseases. Possis is best known for its mechanical thrombectomy devices that are used to treat narrowed or blocked arteries and veins. Medrad believes the firms have "highly compatible sales organizations" and "shared target customer groups." Medrad is also known for winning the Malcolm Baldridge National Quality Award in 2003.
February 11th, 2008
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FDA has cleared the first decellularized replacement heart valve from donated human tissue. Manufactured by CryoLife Inc. (Kennesaw, GA), the allograft uses human tissue from a cadaver and removes the tissue's cells, along with cellular debris. When human tissue is removed from a cadaver, it's inspected and decontaminated. The extra decellularization step taken by CryoLife helps to prevent rejection from the body, because the process leaves a scaffold of connective tissue that works like a human heart valve. The CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft has been cleared for use in patients who need their pulmonary valve replaced as a result of disease, malformation, or the malfunction of their pulmonary valve. The graft could potentially be helpful for children, because allograft heart valves avoid the need for taking blood-thinning drugs for long periods of time.
February 8th, 2008
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A neurostimulator that allows the patient to control the amount of stimulation has been approved by FDA. Medtronic's RestoreUltra neurostimulation system is designed to treat chronic back and leg pain, using electrical impulses at various points on the spine. A feature in the programmer allows patients to make immediate adjustments in their stimulation in order to best address pain fluctuations. On previous devices, such adjustments had to be made in a physician's office. The device is also smaller and thinner than previous models, and on medium setting can go two weeks without having to be recharged. Medtronic intends to begin selling the device by the end of the month.
February 7th, 2008
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The New Jersey Attorney General has read more >>
February 6th, 2008
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Transforming FDA LogoPresident Bush has proposed a $2.4 billion budget for FDA in fiscal year 2009, a 5.7% increase over the current year. That figure includes funds from user fees; without it, the budget comes to $1.77 billion. It includes additional funds targeted at improving the safety of medical devices and other FDA-regulated products, and implements programs to be funded by user fees as per the FDA Amendments Act of 2007. But is it enough? Some think not. The Alliance for a Stronger FDA recommends that Congress...
February 5th, 2008
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Medtronic on Friday received FDA approval for its entry into the embattled but still lucrative drug-eluting stent market, Endeavor. It is the third product of its kind to be cleared for marketing in the United States, and the first since the controversy over the products' potential to cause blood clots led to greater safety scrutiny. CDRH Director Daniel Schultz said approval was granted after the center reviewed "a substantial amount of clinical evidence." Nothing less would have flown in today's climate. Indeed, Medtronic showed the agency data from a whopping seven trials. Their findings included positive data on the device's performance in regards to heart attack, cardiac death, and repeat procedures to re-open the coronary artery. Also importantly, blood-clot risk was similar to that for bare-metal stents. However, the agency advises patients to take blood-thinning...
February 4th, 2008
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Medtronic announced that it has won FDA approval for a new physician-use continuous glucose monitoring system. The firm says the CMGS iPro Recorder is smaller, lighter, and easier to use than previous recorders. It is worn by the patient at home for three days. His or her doctor then reviews the data produced by the recorder and looks for glucose patterns -- many of which would not be detected by other methods. The doctor can then use those patterns to assist him or her in coming up with an optimal therapy. The recorder may be particularly useful for patients who have inconsistently high and low glucose levels.
February 1st, 2008
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Patients with abdominal aortic aneurysms are four times less likely to die if they have a stent-graft procedure than if they have a surgical repair, according to a new study by CMS and doctors at the Harvard Medical School. However, the study, which appears in the New England Journal of Medicine, also found that surgery is more likely to provide a permanent fix for the problem, reports the Wall Street Journal. Many patients and surgeons prefer endovascular repair to surgery because it is much less invasive and recovery is about four times faster.
January 31st, 2008
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