Amplatzer Talisman PFO Occluder and Delivery Sheath Get Nods from FDA

The US Food and Drug Administration (FDA) has approved the Amplatzer Talisman PFO Occlusion System for use in patients with a patent foramen oval (PFO) considered at risk of recurrent ischemic stroke, according to a statement from Abbott.

Announced on September 29, the FDA’s approval was accompanied by the clearance of the Amplatzer Talisman Delivery Sheath, which is used to deliver the occluder during implantation. The approval comes just less than 5 years after the Amplatzer PFO Occluder became the first FDA-approved PFO closure device in October 2016.

"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," said Lee MacDonald, MD, structural cardiologist at South Denver Cardiology Associates, in a statement. "With the new Talisman system now available in the US, doctors can treat a broader range of patient anatomies, and the preparation needed for PFO occlusion procedures is simpler and faster."

According to Abbott, the new generation Amplatzer Talisman PFO Occluder is based on the original Amplatzer PFO Occluder, which was examined in the RESPECT trial. The largest trial ever conducted on PFO closure, RESPECT enrolled 980 who were followed for a median of 5.9 years and demonstrated use of the Amplatzer PFO Occluder was more beneficial for closing the PFO in patients with PFO-associated stroke than medical therapy alone.

On their website, Abbott details a multitude of contraindications and warnings accompanying the Amplatzer Talisman PFO Occluder. Additionally, Abbott notes aspirin or an alternative antiplatelet/anticoagulant is recommended to start at least 24 hours prior to the procedure, antibiotics should be administered peri-procedurally, and patients should be fully heparinized throughout the procedure to keep activated clotting time greater than 200 seconds.

"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."

This is a breaking news story and will be updated when more information becomes available.