October 17, 2018
Cardiac Dimensions' Carillon System Gains Reimbursement Approval in Germany
October 18, 2018—Cardiac Dimensions, Inc. announced that InEK, the German Institute for the Hospital Remuneration System, has granted a permanent diagnosis-related group (DRG) code covering reimbursement for the company’s Carillon mitral contour system to treat patients with functional mitral regurgitation (FMR) in Germany. The new reimbursement becomes effective January 1, 2019.
Previously, the Carillon system was available in limited volumes under the Neue Untersuchungs-und Behandlungsmethoden program. The DRG approval will allow every eligible patient in Germany to have access to the Carillon procedure.
In the company's announcement, Prof. Michael Haude, MD, commented, “This positive decision is good news for patients in need of mitral valve repair due to FMR. The Carillon system provides an important option for patients that is easy to use and that can be used to treat patients earlier in the progression of their disease to prevent worsening quality of life.” Prof. Haude has been treating patients with the Carillon system since the Amadeus study in 2007. He is Director of the Department of Internal Medicine I, Cardiology, at Lukas Krankenhaus Neuss in Neuss, Germany.
According to Cardiac Dimensions, the Carillon system has received CE Mark approval and is available in certain European markets as well as other key geographies. The company expects that the recently released REDUCE FMR data will support the expansion of reimbursement and usage in additional geographies, such as Poland, France, the United Kingdom, and Australia.
Prof. Horst Sievert, MD, presented findings from the REDUCE FMR clinical trial at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California. REDUCE FMR met its primary endpoint of demonstrating a statistically significant reduction in regurgitant volume at 1 year in patients who received the Carillon mitral contour system versus the control cohort, consisting of patients under guideline-directed medical therapy who underwent a sham procedure.
Also in September, the company announced that it had enrolled its first patient in the pivotal CARILLON trial. This is a multicenter, double-blinded, randomized controlled trial expected to randomize 450 patients at up to 75 centers in North America and Europe. The Carillon mitral contour system is an investigational device in the United States, advised Cardiac Dimensions.