Phase III of CoreValve’s international trial for its patented 18-French Revalving System is now one-third enrolled since beginning less than three months ago.
The unique 18-F-sized delivery catheter, has been used successfully to percutaneously implant its proprietary porcine pericardial-tissue bioprosthesis over the diseased aortic heart valves of more than 30 patients in a “cath” lab setting. The safety-and-efficacy clinical trial is expected to enroll 100 patients or more at 12 sites in Europe and Canada.
The most recent ReValving cases in this ongoing clinical trial have been performed without the use of extracorporeal bypass, other cardiac assistance or even rapid pacing. True percutaneous procedures, these implantations were completed within routine interventional times, and, in spite of their high-risk status, patients were released from the ICU within hours of valve implantation and discharged from the hospital within days.
“Accomplishing percutaneous replacement of an aortic heart valve in a cath lab setting, in about 10 minutes excluding prep time, without any assistance whatsoever to the beating heart, is why ReValving has such incredible potential for non-surgically treating the thousands of patients who have diseased aortic heart valves but who are just too fragile to undergo open-chest surgery,” said Jacques Séguin, M.D., Ph.D., chairman, CEO and founder of CoreValve. “The procedural progress made by the clinical investigators since our much smaller, third-generation ReValving System became available is truly astonishing. From my perspective as a cardiac surgeon, I see the ReValving procedure as a real alternative to surgical aortic valve replacement.”
The company says it is on schedule to earn CE Mark approval during 2007 and is targeting first-to-market status for the ReValving System in Europe.”