In efforts to address recent controversy surrounding drug-eluting stents, FDA will be reexamining the safety of these devices. According to today's Boston Globe, the agency announced the formation of a public panel to evaluate the risk of blood clots in patients who have the stents implanted. FDA also released a statement on its website, which says that the panel, consisting of outside experts, will be looking at studies presented in Atlanta and Barcelona. Recent studies have revealed a small but significant risk of blood clots in patients with drug-eluting stents. The panel's evaluation will also determine if more clinical studies must be performed and whether or not anticoagulants should be used for a longer period of time. Currently, FDA states it believes drug-eluting stents are safe and...
Two studies published in the latest edition of the New England Journal of Medicine conclude that drug-eluting stents are safe to implant immediately after a heart attack, Bloomberg News reports. One study compared Johnson & Johnson's Cypher to bare-metal stents. The other compared Boston Scientific's Taxus to bare-metal stents. The Cypher study was more conclusive, finding that both patient groups had the same rate of heart attack and death, and that the bare-metal-stent patients were twice as likely to need another procedure to treat blockages. Only one case of clotting, an emerging concern for drug-eluting stents, was found in the Cypher patients. The Taxus study found lower rates of death, heart attack, and repeat procedures among the Taxus patients, but the researchers couldn't determine whether they were statistically significant.
September 14th, 2006
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FDA has issued a warning letter to Medtronic about problems associated with catheters used with implantable drug pumps, Bloomberg News reports. The agency cited cases where catheter tips have detached inside patients. Medtronic says that most of the problems cited in the letter have already been corrected.
September 13th, 2006
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Stanford University Medical Center (Palo Alto, CA) has a new policy banning all gifts, even the most minor ones, to its doctors from drug and device industry representatives, reports the New York Times. It is the latest academic medical center to toughen up conflict-of-interest policies in the wake of outcries over corporate influence in medicine. The change likely to get the most attention is the banning of free drug samples, but some changes apply to the device industry too. With some exceptions, industry representatives are barred from areas where patient care and doctor education occur. Doctors who buy medical devices must report any relationship with manufacturers, and may be barred from the decision-making process. And they may not publish articles in medical journals that are ghostwritten by industry. Fortunately, consulting arrangements are not affected, indicating that Stanford...
September 12th, 2006
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The Star Tribune of Minneapolis has a device-industry story with an angle not often seen in the mainstream media: A small device company battling back after being left for dead by investors. Possis Medical (Coon Rapids, MN), maker of a system that breaks up and removes blood clots, saw its share price plunge 40% in August 2004 after unfavorable results of a clinical trial were released. A good chunk of its sales force decided to leave the company. Yet the worth of its technology remained. (The unfavorable trial had shown it was of little help to heart-attack patients. Its value has been proven for other patient populations.) On my trip to the Twin Cities a year ago, Possis Medical was one of my stops. I was impressed by how those who remained had great faith in the technology and were determined to see through a company turnaround. Now, with seven applications for new products or new uses for existing products...
September 11th, 2006
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News that its drug-eluting stents could have a higher risk of causing deadly blood clots triggered Boston Scientific's stock to drop more than 3 percent yesterday. The findings of recent stent studies were revealed Sunday at the World Cardiology Congress in Barcelona, Spain. According to the Associated Press, Boston Scientific compared the clotting rates of patients who had the Taxus stent with those who had bare metal stents. The results showed that the Taxus stent carried a higher rate of clotting starting six months after surgery. Boston Scientific reported the findings to FDA at the beginning of August. Despite the statistics, the company's spokesperson, Paul Donovan, stated that an increase in heart attacks or deaths hasn't been seen. Boston Scientific's main competitor in the stent market, Johnson...
September 8th, 2006
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AÂ New York Times article this morning explains how FDA approval of the world's most expensive medical device, an implantable artificial heart, may not mean much financially for its maker, Abiomed Inc., or company shareholders. The heart is too large to fit in half of men and 80% of women, and it carries risks of blood clots and has produced complications when implanted. (A smaller version is in clinical trials but is not expected to be available until at least 2008.) While FDA is allowing it to be implanted into as many as 4000 patients per year, experts expect the actual number to be under 100 per year. Hence, the article points out, the company shifted its focus upon the 2004 hiring of CEO Michael Minogue, and has directed more efforts into heart-assist and blood-pumping devices. It may be the success of those products that ultimately determine the firm's fate.
September 7th, 2006
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Health Hombre, the blog written by reimbursement expert and MD&DI Editorial Advisory Board member Ted Mannen, has an excellent commentary on the legacy of departing CMS Administrator Mark McClellan. He was, Mannen says, the rare public official who "seemed to relish his position not for what it was, but for what it allowed him to do." CMS is perhaps the most cumbersome bureaucracy in the entire federal government. Most of McClellan's predecessors allowed themselves to get swept up helplessly by the tide of red tape and inertia. McClellan swam against it, and his legacy will be a significant one.
September 6th, 2006
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FDA yesterday granted Abiomed Inc. (Danvers, MA) a Humanitarian Device Exemption that will allow it to market the world's first fully implantable artificial heart, the AbioCor, according to the Boston Globe. The HDE is granted when a device can help small numbers of patients who have no alternatives. Abiomed can't sell more than 4,000 of the devices per year and must monitor every patient who receives one. At a price tag of $250,000, the AbioCor is the most expensive and most complex medical device ever made. It aims to prolong the lives of dying patients who are too sick for a transplant. An advisory panel narrowly voted against approval last year, but the agency changed its mind after further review, deciding that patients should have the right to choose whether to receive the heart. The real litmus test, however, will come when...
September 6th, 2006
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