Abbott Gains Premarket Approval for its Amplatzer Talisman Stroke Prevention System

Abbott has received premarket approval from the FDA for its Amplatzer Talisman PFO occlusion system to treat people with a heart defect that puts them at risk of recurrent strokes.

The defect is called a patent foramen ovale (PFO), meaning a small opening between the upper chambers of the heart.

The new device is a further development of Abbotts’ Amplatzer PFO occluder. The Talisman system offers an additional 30-millimeter device size and comes pre-attached to the delivery cable, reducing preparation time.

The FDA also granted 510(k) clearance to the Amplatzer Talisman delivery sheath used to deliver the occluder during implantation.