FDA Panel Will Revisit Boston Scientific's Watchman Data

June 17, 2014—Boston Scientific Corporation has revised the target for US Food and Drug Administration (FDA) approval of the Watchman left atrial appendage closure device from this year to the first half of 2015, according to statements by Dan Brennan, Boston Scientific’s Executive Vice President and Chief Financial Officer, during a presentation at the Wells Fargo Securities 2014 Healthcare Conference in Boston, Massachusetts.

In December 2013, Boston Scientific announced that the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably (Yes: 13, No: 1) that the benefits of the Watchman outweigh the risks, that there is reasonable assurance that the device is safe, and that that there is reasonable assurance of efficacy. The next step anticipated after the panel recommendation was the FDA's considering of the panel’s votes in its decision regarding approval of the Watchman, which the company expected would occur in the first half of 2014. A previous FDA panel had also issued a positive vote for the device.

However, at the Wells Fargo Healthcare Conference, Mr. Brennan stated that the FDA will convene a third panel to review the totality of the clinical evidence that is now available for the Watchman. Mr. Brennan noted that the FDA had not yet scheduled a time for that panel and that an estimate of when approval would be received is subject to the scheduling of the panel and any potential follow-up processes that may be required.

Mr. Brennan said that he was constrained from disclosing specifics about the FDA’s conversations with the company. However, he stated that the company looks forward to presenting the data and is confident that the data support the safety and efficacy of Watchman in the appropriately selected patients.

The Watchman device received European CE Mark approval in 2005 and approval in some Asian countries in 2009. It is currently available in more than 55 countries. In the United States, Watchman is an investigational device, limited to investigational use, and is not available for sale. The device was developed by Atritech, Inc., which Boston Scientific acquired in March 2011.