An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s (NYSE:STJ) Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune.
The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.
The panel found in favor of the device, saying that a long-running study of it showed a “reasonable assurance” that it was safe for use, according to the paper.
The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.
The panel found in favor of the device, saying that a long-running study of it showed a “reasonable assurance” that it was safe for use, according to the paper.
