The U.S. Food and Drug Administration will allow medical devices for the legs coated with the drug paclitaxel to remain on the market, but with increased scrutiny and enhanced patient warnings after the discovery that the devices are associated with long-term higher risks of death.
An updated letter to doctors posted by the FDA on Wednesday says the agency is "working with" devicemakers to include warnings on product labels explaining what's known about the risk. While the agency will continue allowing commercial sales of the devices, patients treated in clinical trials will receive enhanced informed consent disclosures and will be subject to closer ongoing scrutiny by safety-monitoring boards.
"Because of the demonstrated short-term benefits of the devices, the limitations of the available data, and uncertainty regarding the long-term benefit-risk profile of paclitaxel-coated devices, the FDA believes clinical studies of these devices may continue and should collect long-term safety (including mortality) and effectiveness data," the FDA said in a letter Wednesday.
Stock analysts, company officials and researchers said the FDA's announcement was not surprising. Analysts with Needham & Co. said the announcement was likely to increase use and sales of the devices somewhat, but not to the levels that had been projected before the mortality risk was first reported.
Paclitaxel is applied to the outsides of drug-eluting stents and drug-coated medical balloons to cut down on the risk that a diseased femoropopliteal artery in the leg will become reclogged months after being mechanically opened with a device. In patients with severe peripheral artery disease (PAD), the devices are seen as an alternative to surgically attaching a bypass vessel around the blockage.
The FDA created a lucrative and fast-growing product category in 2012 when it approved the nation's first paclitaxel-coated medical device for PAD. Sales of such devices eclipsed $500 million industrywide last year, including Cook Medical's Zilver PTX stent and Medtronic's In.Pact Admiral drug-coated balloon. Boston Scientific's Eluvia stent was seen as a highly promising device approved late last year, and Abbott Laboratories is working with Minnesota's SurModics to bring its own drug-coated balloon to market.
Needham analysts said that although the news was positive for Medtronic and Boston Scientific, paclitaxel device sales account for less than 1% of total revenue at each firm. For SurModics, a smaller company in Eden Prairie, the letter was a "significant positive" that removed uncertainties over its drug-coated balloon device pipeline, which could be worth $92 million in milestone payments from Abbott alone.
Paclitaxel has long been used on coronary stents and in chemotherapy, without the late mortality concerns. The burgeoning field of using paclitaxel to treat PAD had been on a strong upswing until the December issue of the Journal of the American Heart Association brought the growth to a halt.