In addition, the FDA cleared the Amplatzer Talisman delivery sheath.
The Amplatzer Talisman is a next-generation version of the company’s Amplatzer PFO occluder, originally approved in 2016. The Talisman has an additional 30 mm device size, and it cuts the preparation time because all Talisman PFO occluders come pre-attached to the delivery cable.
About a quarter of adults have a patent foramen ovale (PFO) — in which a flap-like opening inside the heart didn’t close after they were babies. A PFO could cause a stroke if blood clots pass from the right side of the heart to the left, enabling them to travel to the brain.
“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,” Dr. Lee MacDonald, a structural cardiologist at South Denver Cardiology Associates, said in an Abbott news release. “With the new Talisman system now available in the U.S., doctors can treat a broader range of patient anatomies, and the preparation needed for PFO occlusion procedures is simpler and faster.”