FDA approves next-generation solution for PFO closure
Abbott’s Amplatzer Talisman PFO Occlusion System for patients with a patent foramen ovale (PFO) has gained FDA approval.
The next-generation solution, a sequel of sorts to Abbott’s Amplatzer PFO Occluder, was designed to treat patients facing a heightened risk of recurrent stroke. It comes pre-attached to its delivery cable and provides clinicians with an additional 30-mm device size.
Abbott’s Amplatzer Talisman Delivery Sheath, which delivers the occluder during implantation, also received FDA approval.
“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,” Lee MacDonald, MD, a cardiologist at South Denver Cardiology Associates, said in a prepared statement from Abbott. “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.”
“Talisman is another example of our commitment to advance innovation of our market-leading heart devices to help people live better lives through better health,” added Michael Dale, senior vice president of Abbott’s structural heart business.
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