Device to help reduce strokes gets FDA approval

A device that could be an alternative to blood thinners for those who are at risk of stroke has received federal approval, an important development for many Tennesseans at risk.

There are few options besides a prescription for blood thinner, such as Coumadin, for those who are at risk for stroke, but its toll affects thousands across the state each year. Tennessee is in the "Stroke Belt" of the U.S. and has about 3,200 deaths per year from stroke, according to the American Heart Association. Nationally about 128,000 people die a year from a stroke.

"The biggest aspect out of this is the potential to decrease the risk of stroke. Strokes so oftentimes don't kill; they oftentimes horribly disable people. We've never had a whole series of options to prevent it," said Dr. Drew Pickett, a cardiologist with Saint Thomas Health, who participated in the federal trials.

"This may ultimately be a chance to start to decrease how often people have strokes," he said.

The Watchman device is inserted into the heart's left atrial appendage, which is the site where 95 percent or more of clots form due to Atrial fibrillation, commonly known as AFib. The device goes into the sac opening, and the body, in the course of healing, scars over the implant, creating a blockage and preventing a clot from forming.

The approval process for the Watchman has taken longer than many other devices, said Pickett, who also is lead investigator on the device. The FDA put it through extra rounds of trials to see how sicker patients responded as well as to understand where there was risk for complications. Saint Thomas is the only site in Tennessee that participated in the trial.

The device will primarily be implanted in patients who are 60 to 80 years old, said Pickett, noting that younger patients often have other options. Patients could be candidates if they have complications or reactions to blood thinner or when "there is a potential risk of problems for being on blood thinner for the rest of your life," Pickett said.

The Centers for Medicare and Medicaid Services has not yet released its reimbursement schedule for the implant.

Manufacturer Boston Scientific is releasing the device to a certain number of hospitals at a time, said Pickett, explaining the training for the implant is rigorous.

"It's going to be a very slow rollout. Again, unlike the way we've done things in the past," he said.

Raymond Francis, 72, of Springfield, was part of the trial. He opted for the implant and came off blood thinner after giving it serious consideration. He worries less about traveling with his wife — severe bleeding from falls or other injuries is a complication of taking blood thinners.

Francis, who walks about two miles a day and exercises seven to eight hours a week, said he feels more aggressive in his workouts.

"(FDA approval) gave me a very gratifying feeling when that happened. They told me I had been part of research that could expand the quality of life for someone else," Francis said. "That for me was the totality of it all, when they put it in someone and had the FDA approval. I'm proud to be part of that."

Reach Holly Fletcher at 615-259-8287 and on Twitter @hollyfletcher.