FDA Tells Providers To Limit Use Of Paclitaxel-Coated Stents
New US FDA analysis of paclitaxel-coated devices to treat peripheral arterial disease matches previous reports of an increased death risk tied to use of the devices. The agency is encouraging providers to look to other treatment options while analysis continues.
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A meta-analysis that seemed to show an increased mortality risk tied to paclitaxel-coated balloons and stents sent shockwaves through the device industry last year. But a more complete data review funded by nonprofit group VIVA Physicians may show that the issue has been overestimated.
The US FDA’s latest update on the safety of paclitaxel-coated balloons and stents urges additional clinical trials. The agency also plans updates to device labeling and clinical trial informed consent documents that will reflect evidence that the devices may pose a mortality risk.
The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.