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 yesterday during a meeting in Gaithersburg, Maryland. Boston Scientific is seeking approval of Watchman to block clots in the heart’s left atrial appendage from causing a stroke.
While the device 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 product 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 Joaquin Cigarroa, a panel member and cardiologist at Oregon Health & Science University.
Some patients on blood thinners struggle with the side effects that make users more susceptible to bleeding when encountering every-day 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, Massachusetts-based Boston Scientific when an initial study showed a high rate of complications.
The panel’s recommendation “represents an important milestone toward making this innovative technology available,” Kenneth Stein, Boston Scientific’s chief medical officer for cardiac rhythm management, said in a statement.
Boston Scientific gained 2.7 percent to $11.48 at 4 p.m. New York time. The shares have doubled in price this year.
The market for devices to close the left atrial appendage may total $400 million, and Watchman may 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. is researching a 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.
Watchman is threaded into the heart, then opens, resembling a parachute made of permeable polyester fabric to block the left atrial appendage. About 90 percent of stroke-causing clots start in the appendage, according to Columbia University’s Center for Interventional Vascular Therapy.
A pivotal clinical trial showed that statistically the device only works as well as standard warfarin-based treatment when the surgical risks of implantation in the first seven days were excluded from results of the study.
Boston Scientific is seeking approval of Watchman for patients who are eligible for warfarin therapy. People who have certain blood disorders or a tendency to hemorrhage shouldn’t take warfarin.