BAINBRIDGE ISLAND, WASH.-- November 02, 2021 -- ReValve Solutions, Inc., an innovator in the field of transcatheter structural heart replacement and repair, announced today it has successfully completed the first human use of its transcatheter, Palmetto System for mitral valve replacement. The patient was successfully treated who suffered from severe mitral valve regurgitation and heart failure. The transfemoral-transseptal procedure was performed at the Italian Hospital in Asuncion, Paraguay by Dr. Charles Davidson, (Medical Director, Bluhm Cardiovascular Institute) and Dr. Edris Aman, (Assistant Clinical Professor of Cardiovascular Medicine at the University of California, Davis Medicine Center specialized in Multimodality Imaging).

"The complexity of mitral valve pathology creates challenges for transcatheter therapies to treat effectively. The first in human experience with this innovative technology shows promise for patients with advanced mitral valve regurgitation,” said Charles Davidson, MD.

"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,” said Edris Aman, MD.

“The case is a major step forward in Re-Imaging the treatment of structural heart disease. Our unique portfolio of technologies is based on our understanding of the evolution of disease and the need to provide for ongoing management of valvular heart disease. I am extremely proud of our team’s focus and dedication,” said Julie Logan Sands, CEO and Founder of ReValve Solutions

The Palmetto System is a complete mitral valve replacement. It is delivered via transfemoral-transeptal procedure. The system is design to avoid any disturbance to the left-ventricular outflow tract and if needed will allow for future valve replacement without compromising the orifice area. Preserving options for the physician and patient is an essential part of the solution to structure heart treatment.