The Tendyne Transcatheter Mitral Valve (TAVI) system has been successfully implanted in three patients. Neil Moat, a leading expert in mitral valve surgery and TAVI, performed the procedures at the Royal Brompton Hospital in London, UK, under a compassionate use protocol.
The patients had severe mitral regurgitation that was eliminated after the procedure was performed via a transapical approach without cardio-pulmonary bypass. Commenting on the procedures, Moat says: “The first patient, a 68 year-old female with severe left ventricular dysfunction and severe functional (secondary) mitral regurgitation, was not considered a candidate for conventional mitral valve surgery at another UK centre. Last month, using a transapical approach, we deployed the Tendyne device, optimising its placement to eliminate mitral regurgitation.”
On the second procedure, Moat comments: “We implanted the Tendyne device in an 85 year-old man with prior CABG and significant renal dysfunction who had severe degenerative mitral regurgitation with chordal rupture and leaflet prolapse. The procedure went smoothly and the patient had no residual mitral regurgitation. A third patient (age 87) with severe degenerative primary mitral regurgitation recently received this novel device at the Royal Brompton, resulting in no residual mitral regurgitation and improved haemodynamics. All three patients made a rapid recovery with no major in-hospital complications. All the patients have been discharged to their own homes.”
The Tendyne TMVI is a fully retrievable and repositionable, apically tethered tri-leaflet porcine pericardial valve sewn onto a Nitinol frame that was specifically designed to address the complex mitral anatomy of functional, degenerative and mixed etiology mitral regurgitation. “Multiple sizes and the flexibility associated with the tether allowed us to treat a wide array of patients. We look forward to continuing to implant the device in a multi-national feasibility study as we move towards regulatory approval. We are one step closer to offering a safe, effective, and minimally invasive option to the millions of patients with mitral regurgitation,” says Jeff Franco, chief executive officer of Tendyne.