FDA Has Calmed Down About Paclitaxel, but Has the Market Recovered?

Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for the drug-coated balloon manufacturers and physicians this year, but there does seem to be some signs of a rebound in the market. The issue was a hot topic last week at Wells Fargo Securities' annual healthcare conference. FDA  eased up on paclitaxel device recommendations in August, seven months after a meta-analysis showed an increased risk of death for patients treated with paclitaxel balloons and stents. The issue drove a market decline of about 50% and was likely a deciding factor in FDA's rejection of Becton, Dickinson and Company's (BD) Lutonix paclitaxel-coated balloon for below the knee peripheral artery disease. FDA's most recent recommendations in August came after a two-day meeting of the Circulatory System Devices Panel in June. The agency concluded at the meeting that there is a signal associated with an increase in mortality through five years of paclitaxel-coated devices as compared to non-coated devices. FDA 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. FDA said it is working with manufacturers on updates to device labeling and clinical trial informed consent documents to incorporate information about the late m...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news