How Boston Scientific Got the Watchman Back on Track

It wasn’t an easy road to obtain FDA approval for Boston Scientific’s Watchman Left Atrial Appendage (LAA) Closure Device.

The Marlborough, MA-based company’s device was rejected by FDA in 2010 because of concerns about procedural complications. After the panel had recommended approval a second time, the agency requested a third-panel review last year - analysts were expecting a narrowed label restricting the manner of use.