First-in-Human Procedures Performed With the Tendyne TMVI System

December 2, 2014—Tendyne Holdings, Inc. announced the first-in-human procedures of the Tendyne transcatheter mitral valve implant (TMVI) system in three patients. Each patient had severe mitral regurgitation (MR) that was eliminated after the procedure, which was performed via a transapical approach. 

According to the company, the Tendyne TMVI is a fully retrievable and repositionable, apically tethered, trileaflet porcine pericardial valve sewn onto a nitinol frame that was designed to address the complex mitral anatomy of functional, degenerative, and mixed etiology MR.  

Neil Moat, MD, performed the procedures at the Royal Brompton Hospital in London, United Kingdom, under a compassionate use protocol in October and early November. 

In the company’s press release, Dr. Moat commented, “The first patient, a 68-year-old female with severe left ventricular dysfunction and severe functional MR was not considered a candidate for conventional mitral valve surgery at another United Kingdom center. Last month, using a transapical approach, we deployed the Tendyne device, optimizing its placement to eliminate MR.”  

Regarding the second procedure, Dr. Moat stated, “We implanted the Tendyne device in an 85-year-old man with previous coronary artery bypass grafting and significant renal dysfunction who had severe degenerative MR with chordal rupture and leaflet prolapse. The procedure went smoothly, and the patient had no residual MR.”

Dr. Moat continued, “A third patient, age 87, with severe degenerative primary MR recently received this novel device at the Royal Brompton, resulting in no residual MR and improved hemodynamics. All three patients made a rapid recovery with no major in-hospital complications. All the patients have been discharged to their own homes."