Boston Scientific’s Watchman Device Wins FDA Support

A U.S. Food and Drug Administration (FDA) advisory panel has approved Boston Scientific Corp.’s Watchman device to be used as a treatment to prevent strokes in patients with irregular heartbeats.

An advisory panel concluded in a 13-1 vote that the product’s benefits outweigh the risks of implantation. 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 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, Bloomberg reported.

A  clinical trial showed that statistically the device works only 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. Natick, Mass.-based Boston Scientific is seeking approval of Watchman for patients who can take warfarin (the device is not recommended for those with certain blood disorders or patients susceptible to hemorrhaging).

“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, said before the Dec. 11 vote.

Some patients on blood thinners struggle with side effects that make them prone to bleeding from minor pricks or bumps.

The FDA is not obligated to follow the panel’s recommendation. The agency had requested a new trial on Watchman in 2010 after rejecting the device when an initial study showed a high rate of complications.

“We are pleased with the outcome of the panel, which represents an important milestone toward making this technology available to patients with AF at higher risk for stroke who need an alternative to long-term warfarin therapy,” Kenneth Stein, M.D., chief medical officer, Cardiac Rhythm Management at Boston Scientific, said in a statement. “We look forward to continuing discussions with the FDA regarding the panel’s comments.”

Industry analysts estimate Watchman could generate $162 million in worldwide sales in 2017, roughly one-quarter of the $400 million global market for such devices. 

Boston Scientific’s Watchman device is threaded into the heart, then opens like a parachute. The product is made of permeable polyester fabric to block the left atrial appendage, where about 90 percent of stroke-causing clots begin.

Watchman already has been approved in Europe, and industry observers expect the FDA to give its blessing during the second quarter of 2014.