After an unusual third review, a panel of doctors has narrowly recommended that the Food and Drug Administration allow Boston Scientific to sell a new heart device to prevent strokes.
But the device, known as Watchman, is likely to be available to a smaller group of patients than the manufacturer wanted.
Invented by a trio of physicians at the Minneapolis Heart Institute in 1996, Watchman is among a handful of cutting-edge devices that are intended to block circulation in the left atrial appendage, which is a sort of cardiac cul-de-sac of the heart where blood can form deadly clots in patients with irregular heartbeats.
The potential market for the device is large, because atrial fibrillation is the most common heart-rhythm dysfunction in the United States. Blood clots that break free from the hearts of patients with atrial fibrillation can be deadly if they reach the brain and cut off blood flow, causing ischemic stroke.
Boston Scientific, which maintains a sizable workforce at its Maple Grove and Arden Hills campuses, is seen by analysts as leading the race for approval of a left atrial appendage plug. St. Jude Medical in Little Canada is assessing a similar device known as the Amplatzer Amulet, but it's still in early data-gathering stages in the United States. Testing by smaller companies is also ongoing.
If the Watchman were approved in 2015, Boston Scientific could sell about $27 million worth of the devices that year, climbing to $90 million in 2018, according to a note to investors from Wells Fargo Senior Analyst Larry Biegelsen.
Although Boston Scientific is leading the pack of medical device companies, the Watchman has hit an unusual level of scrutiny at the FDA.
"It was almost unprecedented to have three panels," Dr. Rob Schwartz, one of the co-inventors of Watchman, said in an interview. "I don't know of anyone who has heard of three panels before. But they wanted to be very clear, because the device was an unusual device and they wanted longer-term follow-up."
