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
0
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
0
The New Jersey Attorney General has read more >>
February 6th, 2008
0
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
0
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
0
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
0
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
0
Transforming FDA LogoFDA is so understaffed that it would, at its present pace, read more >>
January 29th, 2008
0
Eastman Chemical Co., which provides materials used in medical devices, tubing, and packaging, has introduced a new Web site, named the Online Medical Technical Center, that enables users to more easily find information about materials. Information available includes technical specifications, sterilization compatibility, and processing information. "Nowadays, our customers are more technical savvy. They want to do research on their own before they decide to call someone," said Gary Hawkins, technical platform manager for medical packaging and tubing. "Before, a sales, marketing, or technical person had to navigate them through things.
January 29th, 2008
0
A Minnesota company has developed a device that uses electric currents to treat degenerative eye diseases, reports the Star Tribune of Minneapolis. It operates on the same theory as pacemakers and stimulators -- that electricity can be used to modify conditions present in the human body. ScyFix was founded by Thomas Harold, a former General Mills executive with no medical background, who was interested in studies that found that electricity could restore sight. (Drugs can't; they can only prevent further sight loss.) He recruited a team of doctors and engineers who designed a device that uses electrodes to release low-intensity electrical currents into the eyelids. An algorithm tells the device what the amount and frequency of the charges should be. The device has been tested in about 1000 patients in 29 countries since 2002. The company says 95% of them experienced no further...
January 25th, 2008
0