Another FDA setback for Boston Scientific's Watchman stroke-fighting device

Watchman implant--Courtesy of Boston Scientific

The FDA has told Boston Scientific ($BSX) its Watchman implant designed to help prevent strokes in atrial fibrillation patients will have to face a third advisory panel before gaining approval.

The agency's decision was announced by Boston Scientific CFO Daniel J. Brennan at a Wells Fargo investor's conference and was reported by Forbes. Although a date has yet to be set for the FDA panel review, the business magazine said Boston Scientific is anticipating Watchman approval in the first half of 2015.

Last December, the agency's Circulatory System Devices Panel overwhelmingly agreed--the vote was 13-1--that the device's benefits outweighed any risks, and that Watchman was both safe and effective to use for closing off the left atrial appendage to catch blood clots before they migrate to the brain and cause strokes. However, a panel's recommendation isn't a guarantee for approval.

The regulatory agency rejected Watchman in 2010 after a panel endorsement. Concerned about a high rate of complications, a new clinical trial was done that helped reduce the 7-day serious complication rate by nearly half. Yet the study, which was called PREVAIL, missed its second efficacy endpoint and had results that suggested the device wasn't much better than standard care with blood-thinning drugs.

The strength for Watchman as the device continues its grueling regulatory ordeal may be four-year follow-up data from the device's initial trial called Protect AF. That data showed Watchman scored statistically higher than the blood-thinner warfarin at preventing cardiovascular death, all-cause stroke and systemic embolization.

Although other companies such as St. Jude Medical ($STJ) have similar devices yet to be approved, Boston Scientific may still be the first out of the gate for a market the company has estimated to be $500 million.

- read the Forbes story

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