Third Panel’s The Charm For Watchman? More Delays For Boston Sci’s Stroke Device
This article was originally published in The Gray Sheet
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.
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.
Boston Scientific’s Watchman left-atrial appendage occluder for reducing stroke risk in patients at risk for thromboembolism missed both co-primary efficacy endpoints in the latest follow-up data from the PREVAIL study, but at least one analyst believes it still has a good chance of earning another endorsement from an FDA advisory panel in October. And metaanalysis data offered more support.
The FDA Circulatory System Devices Advisory Panel will review Boston Scientific Corp.’s Watchman Left Atrial Appendage Closure Technology and, separately, make recommendations on a group of allograft heart valves at an Oct. 8-9 panel meeting in Gaithersburg, Md.