The company is seeking approval of the Watchman, a stroke-prevention device.
WASHINGTON – Boston Scientific Corp.’s Watchman device won the backing of U.S. advisers to be used as a treatment to prevent strokes in people with irregular heartbeats.
The benefits outweigh risks associated with the surgical procedure to implant the device, advisers to the Food and Drug Administration voted 13-1 Wednesday. Boston Scientific is seeking approval of Watchman to prevent clots in the heart’s left atrial appendage from causing strokes.
While Watchman failed to prevent stokes as well as the standard treatment using the blood-thinner warfarin, the majority of the advisory panel said the similar results between the two didn’t carry as much weight as total long-term data. The panel also heard from patients who used the device in trials and touted its convenience compared with the bleeding risks of blood thinners.
“The issue of having alternatives to anti-thrombotic therapy is desirable to many of our patients — those that are outdoors and like to go mountain climbing, hiking — these are important issues,” said Dr. Joaquin Cigarroa, a panel member and cardiologist at Oregon Health & Science University, during the meeting in Gaithersburg, Md.
Some patients on blood thinners struggle with the side effects that make users more susceptible to bleeding when encountering everyday pricks or bumps that don’t cause most to bleed.
The FDA isn’t obligated to follow the panel’s recommendation. The agency had requested a new trial on Watchman in 2010 after rejecting the device from Natick, Mass.-based Boston Scientific when an initial study showed a high rate of complications.
The market for devices to close the left atrial appendage may total $400 million, and Watchman could generate $162 million in worldwide sales in 2017, Larry Biegelsen, an analyst with Wells Fargo & Co., wrote in a note to clients. Other stroke prevention in the U.S. comes from drugs including warfarin and new anticoagulants such as Eliquis from Bristol-Myers Squibb Co. and Pfizer Inc.
St. Jude Medical Inc., based in Little Canada, is researching a device similar to Watchman. The products from St. Jude and Boston Scientific are already approved in Europe. The FDA probably will approve Boston Scientific’s Watchman in the second quarter of next year and St. Jude’s Amplatzer Cardiac Plug may reach the U.S. market in 2017, Biegelsen said.