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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Transforming FDA LogoFDA is so understaffed that it would, at its present pace, read more >>
January 29th, 2008
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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
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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
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Drug-eluting stents are more effective than bare-metal stents for off-label uses, and they don't present significant safety issues, a new study finds. The University of Pittsburgh study, published in the New England Journal of Medicine, looked at patients who received stents in tricky areas such as where arteries branch or in grafts from previous surgeries. (Drug-eluting stents are only approved for use in short and straight artery segments.) While restenosis (re-narrowing of the artery) occurred more often in off-label uses than on-label ones, it occurred less often with drug-eluting stents than bare-metal ones. There was no difference in death rates. Another study in the same NEJM issue found almost no difference in survival rate between patients who received stents and those who had bypass surgery. However, bypass had better overall results for patients with multiple lesions.
January 24th, 2008
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A stent coated with a polymer that is 25,000 times thinner than a human hair could be a promising alternative to drug-eluting stents (DES). According to its manufacturer, CeloNova BioSciences Inc., the Polyzene-F coating isn't a drug, but rather an inert chemical compound. It is supposed to "hide" the stent from the body so that the body doesn't react to it being a foreign object, as can be the case with bare-metal stents. Preliminary data from a study presented at the International Symposium on Endovascular Therapy demonstrates that Polyzene-F allows the inside of the blood vessel to heal "almost perfectly" in 30 days. When DES are implanted, blood vessel healing can take several months, if healing even occurs at all, according to the study's principal investigator. This study is the first instance that the coated stent has been used in humans. Made of cobalt chromium, the stent has a...
January 24th, 2008
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Northstar Neuroscience's stock price dropped 83.6% yesterday. But it had little to do with the worldwide stock market plunge. Instead, the cause was results from a clinical trial that showed read more >>
January 23rd, 2008
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Today's Star-Ledger of Newark, NJ has an extensive piece on what some advocacy groups see as a troubling trend toward read more >>
January 22nd, 2008
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Last year, FDA convened the device firms that make biliary stents and reminded them not to promote off-label uses. read more >>
January 22nd, 2008
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Singapore's Biosensors International Group announced that it has received a CE Mark for its BioMatrix drug-eluting stent, which will allow it to be sold in Europe, Reuters reports. BioMatrix is the first DES for which one firm owns the patents for the drug, the stent, and the bioresorbable polymer. This could enable the firm to have a financial turnaround; it posted a $3 million loss for the first half of its current fiscal year. Company officials say they expect the firm to post a profit in the next fiscal year. The firm also expects to expand sales in Asia after recently acquiring a Chinese device firm. Biosensors International was named one of MD&DI's 50 Companies to Watch in 2006.
January 18th, 2008
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