|Watchman implant--Courtesy of Boston Scientific|
Boston Scientific ($BSX) won a positive recommendation from an FDA panel for its stroke-fighting Watchman device, even as panel members expressed doubt that the product would work well in patients who are eligible for traditional drug therapy.
The advisory panel voted 6-5, with one abstention, that Watchman's benefits outweigh its risks and that the device could help treat atrial fibrillation by closing patients' left atrial appendage, The Wall Street Journal reports. But panel members were torn over the device's effectiveness, and ultimately decided that Watchman does not work well for patients who can take the blood thinner warfarin. While the panel's recommendations do not guarantee full regulatory approval, they often weigh heavily in the agency's final decision.
The third time could be the charm for Boston Scientific, as the company struggles to obtain approval for its Watchman device. In 2009, a panel voted by a narrow margin to recommend the product, but the FDA in 2010 rejected the device due to safety concerns from a PROTECT AF pivotal trial. The Marlborough, MA-based company then launched a new trial, PREVAIL, which showed that the device helped reduce the 7-day serious complication rate by 49%.
But PREVAIL also found that Watchman was roughly equivalent to blood-thinning drugs in preventing strokes, potentially setting Boston Scientific back on its quest for regulatory approval. The company's saving grace was four-year follow-up data from its PROTECT AF trial, which found Watchman to be statistically superior to drug therapy in preventing atrial fibrillation. In December 2013, a second panel voted 13-1 that the device's benefits outweighed the risks, but the FDA was not convinced and called for a third review.
Full regulatory approval of the device falls in line with Boston Scientific's plan to boost sales and expand its market share. The company estimates the market for stroke-fighting devices at $500 million, and Wells Fargo projects worldwide sales of Watchman will reach $41 million this year and will rise to $170 million in 2018 if the device wins U.S. approval next year, according to the WSJ story. Boston Scientific in July said it expects the FDA to approve Watchman in the first half of 2015.
- read the WSJ story (sub. req.)