VIVA PHYSICIANS TO PARTICIPATE IN FDA HEARING ON DRUG-ELUTING AND DRUG-COATED DEVICES
On June 19-20, VIVA physicians will participate in a Food and Drug Administration Open Public Hearing to addresses the possible correlation between drug-eluting and -coated devices and late mortality at the Gaithersburg Holiday Inn Grand Ballroom in Gaithersburg, Maryland.
VIVA has spearheaded a pan-industry effort to analyze patient level data in an effort to determine the relative safety of these devices.
The general function of the committee is to provide advice and recommendations to the federal agency on its regulatory issues. The meeting will be open to the public.
The committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices.
The FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings.
FDA background material will be posted on its website after the meeting. See fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.