Sam Brusco, Associate Editor11.29.23
ReValve Solutions revealed that 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 successfully treated with its Palmetto system, a transcatheter mitral valve replacement (TMVR) device.
ReValve’s Palmetto was engineered to replace the mitral valve, while preserving the heart’s natural basal left ventricular function. It's delivered via a transfemoral-transseptal approach and allows for future replacement though a dedicated product line.
“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 ReValve founder and CEO Julie Logan Sands. “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.”
The procedure was completed in under an hour, reducing the patient’s mitral regurgitation to trace. ReValve said at 30 days, the patient is still doing well with zero mitral regurgitation and preserved ventricular function.
“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 interventional cardiologist Dr. Charles Davidson, who is medical director at Bluhm Cardiovascular Institute, Northwestern Memorial Hospital and one of the surgeons to perform the procedure.
ReValve’s Palmetto was engineered to replace the mitral valve, while preserving the heart’s natural basal left ventricular function. It's delivered via a transfemoral-transseptal approach and allows for future replacement though a dedicated product line.
“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 ReValve founder and CEO Julie Logan Sands. “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.”
The procedure was completed in under an hour, reducing the patient’s mitral regurgitation to trace. ReValve said at 30 days, the patient is still doing well with zero mitral regurgitation and preserved ventricular function.
“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 interventional cardiologist Dr. Charles Davidson, who is medical director at Bluhm Cardiovascular Institute, Northwestern Memorial Hospital and one of the surgeons to perform the procedure.