Think the Paclitaxel Device Debate Only Impacts Cardio? Think Again

One of the most alarming facts about the ongoing debate regarding a late mortality signal associated with paclitaxel-coated devices is that this isn't the industry's first rodeo with this sort of issue. "Some of us are having a deja vu all over again moment remembering December 2006 when we had the late stent thrombosis issue with paclitaxel- and sirolimus-eluting stents," John Hershfeld Jr, MD said during the second of a two-day FDA advisory panel meeting about the paclitaxel-coated device issue. "That was, like this situation, discovered by independent investigators and not in any way affiliated with the regulatory agency, but turned the industry and the clinical world on its head." And just like the current debate, the late-stent thrombosis concern prompted FDA to hold a special meeting of its Circulatory System Devices Panel to investigate the safety issues of drug-eluting stents and to recommend potential actions the agency should take. "At that time there was a lot of discussion about 'we need better post-market surveillance.' That was 13 years ago and we're having the same conversation now," Hershfeld said. "I would challenge everyone here, this is something that will happen again if we don't close the loop on this process." The key frustration for FDA and the experts who served on the Circulatory System Devices Panel last week (June 19-20) was the fact that a lot of important information that should have come from requir...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news