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  • FDA APPROVES ABBOTT'S AMPLATZER™ TALISMAN™ SYSTEM FOR PFO CLOSURE IN PEOPLE AT RISK OF RECURRENT STROKE

    - Talisman system builds on the minimally invasive Amplatzer PFO Occluder, the world's leading patent foramen ovale (PFO) closure device that has been used to treat more than 180,000 patients worldwide
    - Abbott’s PFO closure technology helps to prevent blood clots from passing from the right to left side of the heart from where they can travel to the brain and cause a stroke
    - The Talisman system offers the industry's widest range of device sizes in the U.S. and the occluder comes pre-attached to the delivery cable, making the device easier for physicians to use

    ABBOTT PARK, Ill., Sept. 29, 2021 — Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Amplatzer™ Talisman™ PFO Occlusion System to treat people with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart – who are at risk of recurrent ischemic stroke. Expanding on the success of Abbott's Amplatzer PFO Occluder, the next-generation Talisman system offers an additional 30mm device size, and all Talisman PFO occluders come pre-attached to the delivery cable, reducing preparation time for doctors. The FDA also cleared the Amplatzer Talisman Delivery Sheath, used to deliver the occluder during implantation.

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