ReValve is a Rosenman Founders Pledge company. From MassDevice

ReValve Solutions announced today that it completed the first human use of its transcatheter mitral valve replacement (TMVR) system.

Bainbridge Island, Washington-based ReValve Solutions said in a news release that the first procedure with its Palmetto TMVR system was performed at the Italian Hospital in Asuncion, Paraguay, by Dr. Charles Davison (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 successfully treated patient suffered from severe mitral valve regurgitation and heart failure.

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

ReValve designed its Palmetto system to be delivered through a transfemoral-transeptal procedure to avoid any disturbance in the left-ventricular outflow tract. If needed, it will allow for future valve replacement without compromising the orifice area, according to the company.

“The case is a major step forward in Re-Imaging the treatment of structural heart disease,” ReValve Solutions CEO & Founder Julie Logan Sands said in the release. “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.”