ReValve Solutions Announces Successful First-in-Human Trial with Next-Generation Technology for Transcatheter Mitral Valve Replacement

IRVINE, Calif.–( BUSINESS WIRE )–ReValve Solutions Inc. (ReValve), which has developed next-generation technology to facilitate transcatheter mitral valve replacement, announced that an 81-year-old man with a history of heart failure, a series of failed surgical bypass grafts, and severe mitral valve regurgitation (MR 4+), was successfully treated with the Palmetto system.

“The ReValve system is a promising technology. The patient’s immediate recovery is quite remarkable, particularly with preserved left ventricular function. The next morning, the patient assured that he was ready to sing again; “We couldn’t have had a better result.”

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The next-generation transcatheter mitral valve replacement procedure was performed with the ReValve Palmetto System on October 11, 2023, at Hospital Punta Pacifica, Panama City, Panama, by interventional cardiologists Dr. Charles Davidson (medical director, Bluhm Cardiovascular Institute, Northwestern Memorial Hospital) and Dr. Temistocles Díaz (chief of Interventional Cardiology at Punta Pacifica Hospital), along with cardiovascular surgeon Dr. Douglas Boyd (professor of surgery, vice president of the Department of Cardiovascular Sciences at the East Carolina University) and echocardiographer Dr. Edris Aman (clinical assistant professor of Cardiovascular Medicine at the University of California Davis Medical Center). The procedure was a success and was performed in less than an hour, reducing the patient’s MRI to traces. At 30 days, the patient continues to have a favorable evolution, no MRI and preserved ventricular function.

ReValve technology was designed to replace the mitral valve while preserving the heart’s natural baseline left ventricular function. “Our transcatheter mitral valve replacement methodology is unique in that we work with the natural movement of the heart, unlike first-generation technologies that require the heart to work around a rigid implant. Our flexibility and the system of four-point fixation ensure a patent LVOT and maintain left ventricular function during recovery,” explained Julie Logan Sands, Founder and CEO of ReValve Solutions. “Until now, many of the issues of neo-LVOT and LV dysfunction were not fully understood or anticipated in first-generation technologies. ReValve’s first-of-its-kind transcatheter mitral valve replacement system is has been carefully designed to expand the treatable population of patients with mitral valve disease,” Sands added.

“The procedure is simple and the valve and delivery system work as intended. The low-profile valve frame and leaflet fixation help prevent LVOT obstruction, which has been a major limitation of several delivery technologies.” “transcatheter mitral valve replacement. This first-in-human experience is very encouraging for extending the transcatheter mitral valve replacement technique to a larger population,” explained Dr. Davidson.

“The ReValve system is a promising technology. The patient’s immediate recovery is quite remarkable, particularly with preserved left ventricular function. The next morning, the patient assured that he was ready to sing again; we could not have had a better result.” better,” Dr. Díaz emphasized.

About ReValve Solutions

The Palmetto system is a complete mitral valve replacement system performed transfemorally and transseptally. The system is designed to prevent any alteration of the left ventricular outflow tract while preserving baseline left ventricular function and, if necessary, allow for future replacement through a specific product line. Preserving options for physician and patient is a critical part of the long-term solution to structuring heart care. ReValve is an investigational device and is not for sale.

ReValve Solutions, Inc. ( www.revalvesolutions.com ) is headquartered in Irvine, California and its mission is to provide innovative solutions to treat structural heart disease with catheter-based procedures that enable long-term treatment options. For more information, visit www.ReValveSolutions.com

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