July 1, 2019
Cardiac Dimensions ®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure, today announced the Carillon Mitral Contour System® has been implanted in 1,000 patients in the United States, Europe, Australia, Turkey, and the Middle East.
Cardiac Dimensions notes the Carillon System is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with MR grades 2+, 3+ and 4+.
“We are proud to be part of this momentous occasion, having treated the 1,000th patient with the Carillon System, in a live case during CSI Frankfurt 2019, where a large, international audience was able to gain an appreciation for this technology’s unique value and versatility,” stated Horst Sievert, MD, Director and Founder of the Cardiovascular Center Frankfurt in Frankfurt, Germany. “The ability to offer patients an early-intervention, non-surgical treatment for mitral regurgitation, while preserving future treatment options is of enormous benefit to my patients suffering from heart failure.”
“This is a highly anticipated milestone for our company as we witness the 1,000th implantation of the Carillon System,” said Gregory D. Casciaro, President and CEO of Cardiac Dimensions. “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’s announcement of the 1,000th implant of the Carillon System precedes the highly anticipated publication of the positive 1-year results of its blinded, multicenter, randomized controlled trial, REDUCE FMR, which are expected to be released in the July 2019 edition of the Journal of American College of Cardiology: Heart Failure. The early data, which was presented at a late-breaking trial session at last year’s Transcatheter Cardiovascular Therapeutics (TCT) conference,1 complements the growing body of evidence demonstrating the consistent and durable effectiveness and safety of the Carillon System.
“This is an exciting time for me and the entire team,” stated Rick Wypych, Chief Financial Officer and Chief Operating Officer and a long-time employee of the Company. “We are honored and proud to be part of this important journey to develop a first-line therapy in the treatment of FMR.” Wypych continues, “2019 is shaping up to be a momentous year for Cardiac Dimensions with new positive data presented at the DGK and TVT conferences, FDA approval of the updated CARILLON clinical trial protocol, and implementation of the German DRG reimbursement code. We are thrilled to have patients continue to benefit from this landmark technology.”