Cardiac Dimensions Announces Late-Breaking Data to be Presented at The Transcatheter Cardiovascular Therapeutics Conference (TCT) 2018
KIRKLAND, WA – September 20, 2018 – Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced that key data from the company’s REDUCE FMR Trial will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, the annual scientific symposium of the Cardiovascular Research Foundation, taking place Sept. 21-25, 2018 in San Diego.
Data from the REDUCE FMR Trial – A Sham-Controlled Randomized Trial of a Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation evaluating the Carillon Mitral Contour System – will be featured during a late-breaking clinical trial session on Sunday, September 23rd at 10:45am PT in the Main Arena II. The REDUCE FMR Trial is a first-of-its-kind randomized, blinded trial evaluating the company’s innovative Carillon System for the treatment of FMR in heart failure patients. Results will be presented by Prof. Horst Sievert, MD, Director of the CardioVascular Center Frankfurt, Sankt Katharinen, and the Department of Internal Medicine, Cardiology, and Vascular Medicine of the Sankt Katharinen Hospital in Frankfurt, Germany.
In addition, Cardiac Dimensions will be hosting an educational symposium – The Carillon Mitral Contour System: Reshaping the Course of Care for FMR – on Monday, September 24 at 7:00am PT. The symposium will include talks on the REDUCE FMR Trial, discussions of regurgitant volume as an endpoint from a core lab perspective, and discussions regarding Cardiac Dimensions’ U.S. randomized sham-controlled pivotal IDE study, The CARILLON Trial.
“We look forward to sharing the data from the randomized, blinded REDUCE FMR trial of our catheter-based alternative to medications and invasive surgery,” said Gregory Casciaro, President and CEO of Cardiac Dimensions. “Our mission is to address the continued need for quality therapies to treat the large population of FMR patients who are not well served by currently available options for improving quality of life.”
About the Carillon Mitral Contour System
The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression and prevent worsening quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. Unlike other mitral regurgitation therapies, the Carillon System replicates traditional surgical standards through a minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.
To date, approximately 900 patients have been treated with the Carillon System throughout the world. Commercially, the Carillon System has its CE Mark and is available in certain European markets as well as other key geographies including Turkey. Clinical data from three completed studies of the Carillon System (AMADEUS, TITAN, and TITAN II) were the basis for CE marking demonstrating safety and performance. Additionally, the CARILLON Trial, the randomized sham-controlled U.S. pivotal IDE study, continues to enroll patients at centers in the U.S. and Europe.
About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany.
The Carillon Mitral Contour System is an investigational device in the U.S. For more information, please visit www.cardiacdimensions.com.
Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.
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NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.
CAUTION: Investigational Device. Limited by United States law to investigational use.