FDA Eases Up on Paclitaxel Device Recommendations

  Medical device companies that sell paclitaxel-coated balloons or paclitaxel-eluting stents have been waiting to see what action FDA would take to address the late mortality signal associated with these devices. The agency provided some clarity around the issue on Wednesday that could drive a rebound in the utilization of paclitaxel devices. Paclitaxel devices came into the spotlight in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. After a two-day meeting of the Circulatory System Devices Panel, FDA concluded that there is a signal associated with an increase in mortality through five years of paclitaxel-coated devices as compared to non-coated devices. The agency was not, however, able to attribute this increased risk to a specific cause, and the committee was befuddled by data discrepancies. To see the list of specific questions the advisory panel tackled during the June meeting, click here. "We believe the updated list broadens the patient population that may benefit from paclitaxel-coated devices," Needham & Co. analyst Mike Matson said in a report Wednesday. "We think that the updated recommendations could allow for paclitaxel-coated device utilization to rebound somewhat but probably not to the levels seen prior to the last FDA recommendations." Matson estimates that the uncerta...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news