Cardiac Dimensions has announced in a press release that its Carillon Mitral Contour System has now been implanted in 1,000 patients in the USA, Europe, Australia, Turkey, and the Middle East. The Carillon System is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+. The 1,000th system was implanted during a live case at CSI Frankfurt 2019.
President and CEO of Cardiac Dimensions, Gregory D Casciaro, states in the press release: “This is a highly anticipated milestone for our company as we witness the 1,000th implantation of the Carillon System. It was not long ago that surgical intervention was the final solution to treating FMR. We are now part of a new paradigm of minimally invasive care that can safely and effectively treat FMR in a wide range of patients. Because the Carillon System preserves mitral valve leaflet integrity, patients can be treated earlier in the highly progressive disease cycle.”
The company also says in the press release that the one-year results of its blinded, multicentre, randomised controlled trial, REDUCE FMR, are expected to be released this month in the Journal of American College of Cardiology: Heart Failure. It says that early data presented at a late-breaking trial session at last year’s Transcatheter Cardiovascular Therapeutics (TCT) conference complements the growing body of evidence demonstrating the consistent and durable effectiveness and safety of the Carillon System.
It adds that the Carillon System is the first and only device to demonstrate a reduction in regurgitant volume and favourable left ventricular remodelling in a blinded, randomised, sham-controlled clinical trial of percutaneous valve therapy. It is CE-marked and approved for investigational use in the USA.