ReValve Solutions Announces Successful First-in-Human with Next Generation TMVR Technology

IRVINE, Calif. -- Businesswire -- ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.

The next generation TMVR procedure was performed using ReValve’s Palmetto System on October 11, 2023, at the Punta Pacifica Hospital, Panama City, Panama by Interventional Cardiologists Dr. Charles Davidson (Medical Director, Bluhm Cardiovascular Institute, Northwestern Memorial Hospital) and Dr. Temistocles Diaz (Chief of Interventional Cardiology at Punta Pacifica Hospital), along with Cardiovascular Surgeon Dr. Douglas Boyd, (Professor of Surgery, Vice Chair, Department of Cardiovascular Sciences, East Carolina University) and Echocardiographer Dr. Edris Aman (Assistant Clinical Professor of Cardiovascular Medicine at the University of California, Davis Medical Center). The procedure was successfully completed in under an hour reducing the patient’s MR to trace. At 30 days, the patient continues to do well with zero MR and preserved ventricular function.

ReValve’s technology is designed to replace the Mitral Valve while also preserving the heart’s natural basal left ventricular function. “Our approach to TMVR is unique in that we work with the natural movement of the heart, as opposed to first-generation technologies which require the heart to work around a stiff implant. Our flexibility and four-point securement system provide a patent LVOT and maintains left ventricular function throughout recovery,” said Julie Logan Sands, Founder and CEO ReValve Solutions. “Many of the issues of Neo-LVOT and LV dysfunction were not fully understood nor anticipated in first generation technologies. ReValve’s first-of-its-kind TMVR is thoughtfully designed to expand the treatable population of patients suffering from Mitral Valve Disease,” added Sands.

“The procedure is straightforward, while the valve and delivery system performed as designed. Leaflet securement along with the low-profile valve frame helps to avoid LVOT obstruction that has been a significant limitation of several TMVR technologies. This first in human experience is very encouraging to expand transcatheter mitral valve replacement to a larger population,” said Dr. Davidson.

“The ReValve system is a promising technology. The immediate patient recovery is quite remarkable with preservation of the left ventricular function. The next morning the patient stated he was ready to sing again, we could not have had a better outcome,” said Dr. Diaz.

About ReValve Solutions

The Palmetto System is a complete mitral valve replacement system delivered via transfemoral-transseptal approach. The system is designed to avoid any disturbance to the left-ventricular outflow tract while preserving the basal left ventricular function and if needed, will allow for future replacement through a dedicated product line. Preserving options for the physician and patient is an essential part of the long-term solution to structure heart treatment. ReValve is an investigational device only and not available for sale.

ReValve Solutions, Inc. (www.revalvesolutions.com) is based in Irvine, CA with the mission of delivering innovative solutions to structural heart disease through catheter-based procedures which allow for long-term treatment options. For more information visit www.ReValveSolutions.com

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