News | December 06, 2006

Rapid Enrollment Proceeds for Aortic “Revalving”

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.”

Related Content

New Consensus Document Explores Optimized Care for Valvular Heart Disease Patients
News | Heart Valve Technology | April 22, 2019
April 22, 2019 — Five cardiovascular professional societies released a new consensus document on optimizing care for
Mick Jagger Recovering After TAVR Procedure
News | Heart Valve Technology | April 08, 2019 | Jeff Zagoudis, Associate Editor
Rolling Stones frontman Mick Jagger is reportedly recovering after undergoing a transcatheter aortic valve valve...
 Evolut Low Risk Trial compared the minimally invasive Evolut transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients. The randomized trial, which met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3 vs. 6.7 percent; posterior probability of non-inferiority >0.999), was presented at the American College of Cardiology (ACC) 2019 meeting
News | Heart Valve Technology | April 03, 2019
April 3, 2019 – The ACC.19 late-breaking landmark Evolut Low Risk Trial compared the minimally invasive Evolut transc
TAVR Outperforms Surgery in Younger, Low-Risk Aortic Stenosis Patients
News | Heart Valve Technology | March 22, 2019
Among patients with severe symptomatic aortic stenosis at low surgical risk, transcatheter aortic valve replacement (...
ACC Launches Transcatheter Valve Certification
News | Heart Valve Technology | March 14, 2019
March 14, 2019 — Beginning in mid-2019, hospitals performing...
FDA Approves MitraClip for Use in Heart Failure Patients With Functional Mitral Regurgitation
Feature | Heart Valve Technology | March 14, 2019 | Jeff Zagoudis, Associate Editor
March 14, 2019 — The U.S.
Scientists Discover New Type of Immune Cells Essential for Forming Heart Valves

Microscopic images of a normal heart valve in a mouse, left, and a heart valve grown in a lab with heart-derived macrophages blocked, right. Without those macrophages, the valves are thick and deformed. Image courtesy of Developmental Cell/UCLA Broad Stem Cell Research Center.

News | Heart Valve Technology | March 06, 2019
UCLA researchers have identified for the first time the origin of an immune cell that plays a critical role in the...
Overlay Init