Abbott has received an FDA approval for the newest version of its cardiac implant, designed to seal off an opening between the heart’s chambers and ultimately reduce a person’s long-term risk of stroke.
The Talisman device builds off the company’s previous Amplatzer occluder for treating a patent foramen ovale, a gap that forms during fetal development and allows blood to pass through the heart’s right and left atria.
This hole fails to close naturally after childbirth in about 25% of people, and, among those at a higher risk of recurring stroke, it may allow blood clots to pass directly from the veins, through the heart and to the arteries leading to the brain.
According to the company, the established, minimally invasive Amplatzer system has already been used to treat more than 180,000 patients globally over the past 20 years, while the latest Talisman device adds a wider range of sizes for various patient anatomies.
An additional FDA green light covers a preassembled, ready-to-use delivery sheath and cable system, which also allows the implant to be recaptured and repositioned during a procedure.
This past August, Abbott received an FDA approval for another device in its Amplatzer line: the Amulet heart plug, for closing off the organ’s left atrial appendage—a small flap in the muscle wall that can also present a stroke risk.
Previous clinical data showed the procedure can help lower the annual rate of ischemic cases by two-thirds, with the appendage being responsible for more than 90% of stroke-causing clots in these patients.
More recently, however, an analysis published in JAMA Cardiology that tracked the safety of nearly 50,000 transcatheter left atrial appendage occlusion procedures—in this case focused on Boston Scientific’s Watchman competitor—found that major side effects were more common in women than in men. These included statistically significant increases in the rates of bleeding, fluid buildup and procedure-associated deaths.
In a subsequent alert to healthcare providers, the FDA said it would work with Boston Scientific and Abbott—the two makers of such devices approved in the U.S.—to evaluate safety data from a number of different sources. While the root cause of the difference has not yet been determined, the agency said it believes the implants’ benefits currently continue to outweigh the risks.