Patent foramen ovale closure device nets FDA approval
Abbott announced that the FDA has approved its patent foramen ovale occlusion system for patients with a PFO and prior stroke at risk for recurrent ischemic stroke.
According to a company press release, the next-generation system (Amplatzer Talisman) includes an additional 30 mm device size, and all occluders come preattached to the delivery cable.
According to the release, the FDA also approved the delivery sheath used to deliver the occluder during implantation.
A PFO is a hole in the heart when the foramen ovale does not close as it should following birth; this may allow blood clots to pass from the right to the left side of the heart where they may travel to the brain, causing a stroke. According to the release, occlusion of the PFO seals the opening and reduces risk for another stroke in patients with a PFO who previously had a stroke.
“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, structural cardiologist at South Denver Cardiology Associates, said in the release. “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.”
Collapse