A test designed to measure the durability of CoreValve’s ReValving device reached 200 million cycles, the company has reported. CoreValve’s chairman, CEO and founder, Dr. Jacques Seguin, says initial findings indicate its proprietary porcine pericardium aortic heart valve behaves, in vitro, better than tissue valves.
The valve is parts of its ReValving System for percutaneous aortic valve replacement (PAVR).
Condensing equivalent years of service life into months of testing, the company indicates it is applying advanced control and data-acquisition methods to monitor valve function and integrity. Testing is being conducted under strictly controlled regulatory guidelines.
"This event represents another mission-critical milestone toward marketing clearance in Europe as well as commencement of clinical trials in the United States," added Rob Michiels, president and COO of CoreValve