Panel Endorses Atritech Watchman Stroke-Prevention Device In Close Vote
This article was originally published in The Gray Sheet
An FDA advisory committee narrowly elected to recommend approval of Atritech's Watchman minimally invasive stroke-prevention device for atrial fibrillation patients, overcoming doubts about the size of the device's pivotal trial
You may also be interested in...
Since the FDA approval of Boston Scientific Corp.'s WATCHMAN device in March, the US market for left atrial appendage closure devices has reached a tipping point. With first-to-market advantage in the US, and a four- to five-year lead on the competition in bringing a LAAC device to the US market, BSX is well positioned to gain a strong foothold in this potentially billion dollar plus market; however, several factors will dictate market adoption of these devices in the US, including reimbursement, clinical efficacy, cost and ease of use.
FDA has requested that a PMA for Boston Scientific’s Watchman left atrial appendage closure device for stroke-prevention be subject to another advisory panel meeting -- the third since 2009 -- which will delay the launch to, at earliest, the first half of 2015, the company says.
FDA’s Circulatory System Devices advisory panel voted 13-1 to recommend approval of the firm’s PMA for the Watchman device as an alternative to warfarin therapy for stroke prevention in atrial fibrillation patients for whom long-term anticoagulant therapy is too risky.