FDA panel hears from locals on heart device

Research nurse Marsha Jones, from left,  patient Patrick Clemens, of Amory, and Tupelo cardiac electrophysiologist Dr. Jim Stone testified before an FDA advisory panel about who is participating in a clinical research trial for a new device designed to reduce the stroke risk in people with atrial fibrillation. (Courtesy photo}

Research nurse Marsha Jones, from left, patient Patrick Clemens, of Amory, and Tupelo cardiac electrophysiologist Dr. Jim Stone testified before an FDA advisory panel about who is participating in a clinical research trial for a new device designed to reduce the stroke risk in people with atrial fibrillation. (Courtesy photo}

By Michaela Gibson Morris

Daily Journal

TUPELO – If a new device to help reduce stroke risk gains FDA approval later this year, three Northeast Mississippians will share in the success.

Tupelo cardiac electrophysiologist Dr. Jim Stone, Cardiology of North Mississippi research nurse Marsha Jones and patient Patrick Clemens of Amory testified before an FDA advisory panel in December about the Watchman device, which blocks off a back alley in the heart where potentially dangerous clots form.

“My role was to show that you don’t have to be at Mayo Clinic to do this well,” said Stone, who with a team has used minimally invasive techniques similar to angioplasty to place the Watchman device in 32 patients over three years at North Mississippi Medical Center as part of a national study.

About the width of a coin, the Watchman is made from mesh pulled over an expandable metal frame. It is maneuvered into place to block the atrial appendage.

“Everyone has a left atrial appendage on the left side of your heart,” Jones said. “It’s a small pouch, about the size of your thumb.”

Of all the strokes associated with atrial fibrillation – the heart quivers instead of beating properly – about 91 percent are connected with the left atrial appendage, Stone said.

People with atrial fibrillation and other factors that put them at high risk of stroke typically have to take blood thinners to try to prevent the dangerous clots. But the blood thinners increase the risk of uncontrolled bleeding and require close monitoring.

Clemens in particular had trouble with the blood thinners.

“Anything I got around, I bled,” Clemens said. “I’m still active and I wanted to stay active.”

Patients with the device are able to stop taking blood thinners 45 days after the procedure, when doctors have determined it has remained properly placed, Stone said. They continue to take aspirin.

The advisory panel voted to recommend approval of the Watchman, 13 to 1.

Full FDA approval is pending, with a decision expected late spring or summer.

After FDA approval, there will be business and insurance processes that must be completed before the device is offered to patients, but Stone is hopeful that patients will be able to receive the devices later this year.

For Clemens, his personal verdict is already in.

“It’s knowing you’re not at high risk of a stroke any more,” Clemens said.

michaela.morris@journalinc.com