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Abbott�s and Medtronic�s new stents may be easier to insert, but not safer than earlier generation products

According to a report in the Financial Times, two drug-eluting stents entering the medical device market are easier for surgeons to insert, but their safety and efficacy profiles will be comparable to their predecessors, physicians told Pharmawire. And the prior stents have shown problems, so this is not a step in the right direciton.

Stents and Angioplasty: Do these procedures protect against heart attacks?

Recent articles in the New England Journal of Medicine have editorialized on the effectiveness of stents and angioplasty vs. other methods of medical therapy heart attack prevention techniques. The use of stents and angioplasty decreased chest pain and short term performance but did not prevent heart attacks and death. (Read Article)

NY TIMES REPORTS: New Trial Shows Drugs Equal Benefits of Artery Stents by Barnaby J. Feder

Many heart patients routinely implanted with stents to open arteries gain no lasting benefit compared to those treated with drugs. According to the study, patients treated withs tents don't live longer. This puts the entire stent industry into question. Clearly this study will decrease the use of stents by cardiologists. If drugs work just as well, except in the initial time frame right after a heart attack, then there seems to be little reason to implant a permanent device into the patient. Adding to this is the increased risk identified in some studies of medicated staents actually causing heart attacks later. So if ther eis no long term benefit and poerhaps an added long term risk, maybe doctors willstart to seek alternatives to the stent procedures.

Keith J. Winstein, Wall Street Journal 3/15/07 (Subscription Only) - Reports on Biliary-Stents

FDA Contests Biliary-Stent Marketing: "Food and Drug Administration staffers warned makers of bile-duct stents that the agency believes a number of them may be promoting the devices for unapproved vascular uses. At a Monday meeting in Washington with 10 to 20 stent makers, FDA staffers, including the head of its medical-devices unit, instructed manufacturers to detail how they would rein in their sales staffs, according to several people familiar with the matter. The agency displayed manufacturers' Web sites that it said crossed the line into unauthorized territory. It is illegal to market devices for uses other than those for which they were approved."

Boston Scientific's Stent Sales Fall

Boston Scientific Corp. said fourth-quarter sales of its Taxus drug-coated stent fell nearly 12 percent from the previous quarter, but the medical device maker expects the slumping stent market to rebound from recent safety worries. Boston Scientific said sales... (Read Article)

Johnson & Johnson Gets OK to Buy Stent Maker

Johnson & Johnson received clearance from U.S. antitrust regulators to complete its $1.4 billion acquisition of Conor Medsystems Inc., a maker of heart devices.

The proposed transaction is expected to close after a meeting of Conor stockholders set for Jan. 31.

Conor Medsystems, based in Menlo Park, Calif., develops drug-coated stents that use absorbable materials to reduce the risk of blood clots.

Drug-coated stents from Johnson & Johnson and Boston Scientific Corp. were linked to blood clots in recent studies, and third-quarter sales of the devices fell. Conor's stent, which delivers multiple drugs through a coating later absorbed by the body, would give Johnson & Johnson a product that hasn't shown the same risk in trials.

2007-01-08 to 2007-01-14 « 



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