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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Researchers at Wake Forest University have discovered that variations in five regions of DNA are indicators of whether a man will develop prostate cancer. They have developed a DNA test and formed a company called ProActive Genetics to sell it for under $300, reports the New York Times. The test could be the first step in a revolution in medical prognostication. While it is not a surefire predictor of who will actually come down with prostate cancer, it can identify who should have aggressive screening and who probably shouldn't bother. Of course, the potential is also there for it to lead to unnecessary surgeries. If handled correctly, the test could save money and lives down the road. But patients and doctors will have to consider its results carefully.
January 17th, 2008
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Stryker has received its second warning letter in less than a year over manufacturing problems that could lead to malfunctioning hip parts, Reuters reports. A warning letter posted yesterday on FDA's Web site (but issued on Nov. 28) outlined infractions at Stryker's Mahwah, NJ plant, including failure to fix quality problems. It cited complaints about "squeaking noises" from ceramic-based hip implants, and said additional surgeries to alleviate fractures and pain were needed for some patients. The firm says it has been working with FDA since July 2007 on the problems. Last March, Stryker received a warning letter for a plant in Ireland that also makes hip implants.
January 16th, 2008
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FDA yesterday issued a notice to healthcare practitioners with recommendations about how to prevent device fragments from breaking off and staying in a patient's body, and steps to take should it happen. It also encouraged use of the MedWatch system to report such events. CDRH receives nearly 1000 reports per year on adverse events related to unretrieved device fragments.
January 16th, 2008
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Recent research from the Rosalind Franklin University of Medicine and Science in Chicago has shown that if diabetics get "hot spots" on their feet, that is an early indication of foot ulcers, which can lead to foot amputation. Unfortunately, diabetes often causes foot numbing, so patients may not be able to sense "hot spots" before they turn into foot ulcers. A special kind of foot thermometer can help them stay on top of the problem, according to an Associated Press report. Inflammation, an indication of tissue injury, can be measured by an increase in temperature. And a sudden rise can mean that a foot ulcer is about to break out. Right now, there is only one foot thermometer on the market, the TempTouch, a handheld device, made by Xilas Medical Inc. But typically with mainstream media coverage, the firm isn't mentioned by AP until...
January 16th, 2008
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