ReValve Solutions Announces FIH Use of the Palmetto System for Mitral Valve Replacement

November 1, 2021—ReValve Solutions, Inc. announced the successful first-in-human (FIH) use of its Palmetto transcatheter system for mitral valve replacement. The transfemoral-transseptal procedure was performed at the Italian Hospital in Asuncion, Paraguay, for a patient with severe mitral valve regurgitation and heart failure.

According to the company, the Palmetto system is a complete mitral valve replacement designed to avoid disturbances to the left-ventricular outflow tract. The system can allow for future valve replacement if needed without compromising the orifice area.

Charles Davidson, MD, Medical Director at Bluhm Cardiovascular Institute in Chicago, Illinois, and Edris Aman, MD, Assistant Clinical Professor of Cardiovascular Medicine at the University of California, Davis Medicine Center in Davis, California, completed the procedure.

“The complexity of mitral valve pathology creates challenges for transcatheter therapies to treat effectively,” stated Dr. Davidson. “The FIH experience with this innovative technology shows promise for patients with advanced mitral valve regurgitation.”

Dr. Aman commented in the announcement, “The features of the Palmetto system allow for transseptal mitral valve replacement in native mitral regurgitation. This case highlights the potential for this technology, which is another step forward for transseptal mitral valve replacement.”