FDA Approves New Occlusion System for Treatment of Patent Foramen Ovale to Prevent Recurrent Stroke

The Food and Drug Administration (FDA) has approved a new occluder (Amplatzer Talisman; Abbot, Chicago, IL) for treatment of patent foramen ovale (PFO) in individuals at risk of a recurrent stroke. The FDA also cleared the delivery sheath, used to deliver the occluder during implantation.

The next-generation occlusion system offers an additional 30-mm device size. In addition to its wide range of sizes, all occluders come preattached to the delivery cable, reducing preparation time before the procedure, and increasing its ease of use. The occluder is fully recapturable and repositionable to ensure optimal placement.

“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 Upp, doctors can treat a broader range of patient anatomies, and the preparation needed for PFO occlusion procedures is simpler and faster.”