FDA Approves Heart Valve Trial
The U.S. Food and Drug Administration (FDA) has given conditional approval to Edwards Lifesciences Corp. to begin a clinical trial to measure valve safety and effectiveness of an experimental tissue treatment for replacement heart valves.
The company will test the GLX tissue treatment platform, which allows for dry packaging and sterilization of pericardial heart valves made from cow tissue. The technology looks to eliminate the need for rinsing the valve before it is implanted, and to provide additional protection.
Meanwhile, the ACC will be testifying Wednesday, June 13 at an FDA meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in response to the pre-market approval application of Edwards Lifesciences SAPIEN Transcatheter Heart Valve. Stay tuned to CardioSource.org for updates from that hearing.
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