Abbott’s Amplatzer Talisman PFO Occlusion System Approved by FDA

September 29, 2021—Abbott announced that the FDA has approved the company’s Amplatzer Talisman patent foramen ovale (PFO) occlusion system to treat patients with PFO at risk of recurrent stroke. The FDA also cleared the Amplatzer Talisman delivery sheath, used to deliver the occluder during implantation.

Expanding on the company’s Amplatzer PFO occluder, the next-generation Talisman system offers an additional 30-mm device size. In addition to its wide range of sizes, all Talisman PFO occluders come preattached to the delivery cable, reducing preparation time before the procedure, and increasing its ease of use. Talisman is fully recapturable and repositionable to ensure optimal placement, stated Abbott.

“Extensive clinical trial data and the latest guidance from industry organizations support PFO closure as an important treatment option to reduce risk of recurrent stroke in patients,” commented Lee MacDonald, MD, in Abbott’s press release. Dr. MacDonald, who is a structural cardiologist at South Denver Cardiology Associates in Littleton, Colorado, continued, “With the new Talisman system now available in the United States, doctors can treat a broader range of patient anatomies, and the preparation needed for PFO occlusion procedures is simpler and faster.”