6/22/2023 0 Comments Infuse medtronicThe drug-coated stents were considered an improvement over bare-metal stents, which were associated with a high restenosis rate. "It should have gone through the biological testing process."Ībout the same time Infuse was approved, the FDA required more extensive testing prior to the approval of another type of combination device - drug-eluting stents used in PCI. "It should not have gone through the device approval process," said Brook Martin, PhD, a health researcher in orthopedic surgery at Dartmouth-Hitchcock Medical Center. In addition, Infuse was approved in a "noninferiority" trial, meaning Medtronic did not have to prove it was any better than the traditional treatment.Īs a result, Infuse got on the market with less safety testing than other biologic drugs. But in allowing Infuse on the market, the FDA treated it as a combination device, rather than as a biologic agent, with only 277 patients in the clinical trial. Testing of new biologic agents generally requires clinical trials with 1,000 to 3,000 people. Moreover, Infuse is not an inexpensive treatment option: a paper published in the Spine Journal in January found that use of BMP-2 increased the typical hospital charge by more than $13,000 per patient, more than $900 million in total, from the years 2002 to 2008. Last week, the company told investors it will pay $22 million to settle about 950 claims and is setting aside $140 million to settle an anticipated 3,800 additional claims. Roughly half of those - some 3,300 - were filed last year alone. Food and Drug Administration data found more than 6,500 reports of Infuse-related problems have been registered with the agency's medical device reporting system since 2002, the year Infuse was approved. That number of plaintiffs likely will grow.Ī Journal Sentinel/MedPage Today analysis of U.S. ![]() resident became one of nearly 1,000 people who are suing Medtronic, the company that markets Infuse, a spinal fusion device that elutes bone morphogenetic protein-2 0r BMP-2.
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