ReValve Solutions has announced the successful first-in-human use of its Palmetto transcatheter mitral valve replacement (TMVR) system.
The patient, an 81-year-old male, with a history of heart failure, a series of failed surgical bypass grafts and severe mitral regurgitation (MR 4+), was treated 11 October at the Punta Pacifica Hospital (Panama City, Panama) by interventional cardiologists Charles Davidson (Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Chicago, USA) and Temistocles Diaz (Punta Pacifica Hospital, Panama City, Panama), along with cardiovascular surgeon Douglas Boyd (East Carolina University, Greenville) and echocardiographer Edris Aman (University of California, Davis Medical Center, Sacramento).
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, the company said in a press release.
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 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 Diaz.
