An initial review of the premarket approval application for the ATS 3f(R) Aortic Bioprosthesis Heart Valve has been completed by The Center for Devices and Radiological Health FDA.
The ATS 3f(R) brand — by ATS Medical, Minneapolis, MN — encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less invasive valve replacement technology.
Company chairman and president says it’s an important milestone along the path to U.S. market approval of the device.
"The $700 million tissue heart valve market is the fastest growing segment within the $1.2 billion heart valve therapies marketplace,” said Michael Dale.” We believe that ATS 3f tissue heart valve technologies offer added value and therapeutic options for clinicians and patients, and we look forward to working closely with the FDA to bring these products to market."
For more information visit www.atsmedical.com.