KIRKLAND, Wash., July 1, 2019 /PRNewswire/ -- 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. 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."
About the Carillon Mitral Contour System
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair (TMVr) designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart's venous anatomy to cinch the mitral apparatus without compromising the valve or future treatment options.2,3 The Carillon System is designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a blinded, randomized, sham-controlled clinical trial of percutaneous valve therapy.1
The Carillon System is CE-marked (0344) and has been implanted in 1000 patients in Europe, Australia, Turkey and the Middle East. The Carillon System is approved for investigational use in the United States.
About Cardiac Dimensions, Inc.
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company is funded by Aperture Venture Partners, Arboretum Ventures, Difference Capital, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia and Germany. For more information, visit cardiacdimensions.com.
1. Sievert, H. 2018. REDUCE-FMR: A Sham Controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.
2. Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
3. Latib, A. "Coronary Sinus Annuloplasty." New York, Montefiore Medical Center. Miami Valves Conference. February 2019
SOURCE Cardiac Dimensions, Inc.