Cardiac Dimensions Announces Investigational Device Exemption Approval from FDA
admin December 1, 2016 Portfolio News, Cardiac Dimensions
Cardiac Dimensions Announces Investigational Device Exemption Approval from FDA to Conduct U.S. Pivotal Study of the Carillon Mitral Contour System for Functional Mitral Regurgitation
First U.S. Randomized, Double-Blinded Study for this Underserved Patient Population
Kirkland, WA – Dec. 1, 2016 – Cardiac Dimensions, the leader in minimally invasive repair therapies for functional mitral regurgitation (FMR), today announced U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application for the pivotal CARILLON trial. The multi-center, blinded, randomized controlled trial is designed to evaluate the Carillon® Mitral Contour System® versus guideline directed medical management for the treatment of symptomatic FMR associated with heart failure (HF), a condition affecting an estimated 2 million people in the U.S.1,2
"This CARILLON trial is an important next step to potentially advance the treatment of patients with functional mitral regurgitation," said Martin B. Leon, M.D., Professor of Medicine and Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center and chairman of the CARILLON trial clinical steering committee. "There is a significant need for a new minimally invasive solution for this extremely ill and underserved patient population, as current mainstream therapies are limited."
The CARILLON trial is designed to enroll 400 patients at up to 50 centers in North America, Europe and Australia. The trial has primary safety and efficacy endpoints at 12 months and will follow patients to document long-term safety.
"The Carillon device is unlike any other mitral regurgitation therapy. It offers patients annular reduction and keeps adjunctive therapy options open," said Samir Kapadia, M.D., Professor of Medicine and Director of the Sones Catheterization Laboratories at Cleveland Clinic and one of the principal investigators of the CARILLON trial. "I am excited to participate in this important pivotal trial and look forward to the results."
The Carillon system has been studied in three multi-center, prospective clinical trials conducted in Europe and in all studies successfully achieved endpoints of low event rates and reduction of regurgitant volume.3-5 Another clinical trial, REDUCE FMR, is currently recruiting participants and is designed to enroll 120 patients at approximately 25 centers in Europe, Australia and New Zealand.
"The approval of the IDE for the Carillon system is a significant milestone for our company," said Gregory D. Casciaro, President and CEO of Cardiac Dimensions. "We have seen substantial interest and adoption of the Carillon system in Europe and are excited to take the first step to bring this innovative treatment to patients and physicians in the United States."
About FMR
FMR primarily results from the enlargement of the left ventricle causing the mitral annulus to dilate, allowing blood to flow back into the left atrium. Medical therapy is the current standard of care, though many patients remain symptomatic. If left untreated or undertreated, the condition overloads the heart and leads to or accelerates HF. In the U.S., HF is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.6
About the Carillon Mitral Contour System
The Carillon Mitral Contour System, comprising an implantable device and delivery system, offers a simple percutaneous coronary sinus-based approach to mitral valve annuloplasty to address the primary cause of FMR. The implantable device uses distal and proximal anchors along with its shaping ribbon to cinch the dilated mitral annulus. This approach improves the natural flow of blood through the heart, stimulates reshaping of the left heart for long-term sustained results, and preserves all adjunctive treatment options making the Carillon system the ideal first-line therapy for FMR.
The Carillon system has CE Mark approval and has been implanted in approximately 700 patients in Europe, Australia, New Zealand and the Middle East. The system is not approved for sale in the United States.
About Cardiac Dimensions
Cardiac Dimensions is the leader of minimally invasive mitral valve repair therapies for FMR. The company's initial technology platform, the Carillon Mitral Contour System, addresses the primary cause of FMR utilizing a novel percutaneous coronary sinus-based approach. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany. For more information about Cardiac Dimensions, visit www.cardiacdimensions.com.
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2. Patel JB, Borgeson DD, Barnes ME, el at. Mitral regurgitation in patients with advanced systolic heart failure. J Card Fail. 2004;10(4):285-91.
3. Schofer J, et al. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the Carillon Mitral Annuloplasty Device European Union Study. Circulation. 2009;120(4):326-33.
4. Siminiak T, et al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012;14(8):931-8.
5. Lipiecki J, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. Open Heart. 2016 Jul 8;3(2):e000411
6. Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart Failure in the United States. Circ Heart Fail. 2013;6(3):606-19.