Abbott has announced that the US 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 ischaemic stroke. 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.
Abbott’s next-generation Talisman system builds on the company’s Amplatzer PFO Occluder, which has more than two decades of safety and effectiveness data and is approved in the USA designed specifically to close the PFO. The Talisman system provides the widest range of PFO occluder sizes in the USA through the addition of the new 30mm offering, Abbott said in a press release. Additionally, the Talisman device comes pre-attached to the delivery cable, reducing prep time ahead of the procedure and making it easier to use. Talisman is fully recapturable and repositionable to ensure optimal placement.
“Extensive clinical trial data and the latest guidance from industry organisations support PFO closure as an important treatment option to reduce risk of recurrent stroke in patients,” said Lee MacDonald, structural cardiologist at South Denver Cardiology Associates. “With the new Talisman system now available in the USA, doctors can treat a broader range of patient anatomies, and the preparation needed for PFO occlusion procedures is simpler and faster.”
“Abbott’s Talisman system improves the efficiency and effectiveness of the PFO occlusion procedure,” said Michael Dale, senior vice president of Abbott’s structural heart business. “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.”