Analysis Demonstrates Benefits of Cardiac Dimensions' Carillon Mitral Contour System
June 13, 2019—Cardiac Dimensions, Inc. presented data showing that increased mitral valve tenting was associated with an improvement in regurgitant volume with use of the company's Carillon mitral contour system. Carillon is a right heart transcatheter mitral valve repair (TMVR) device designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+, and 4+. Steven L. Goldberg, MD, presented the data at the TVT 2019 Structural Heart Summit held June 12–15 in Chicago, Illinois.
Previous studies have shown that increased tenting dimensions predict residual or recurrent MR after surgical restrictive annuloplasty. According to the company, the presented findings are from a retrospective analysis of 125 patients who were treated with the Carillon device and were enrolled in the TITAN, TITAN II, and REDUCE FMR clinical studies to assess the consistency of this predictive assessment. Investigators studied the relationship between baseline tenting area and tenting height (coaptation distance) on percent regurgitant volume change and percent left ventricular (LV) end-diastolic volume change.
In the company's press release, Dr. Goldberg commented, "This data confirms that, unlike surgical annuloplasty, increased tenting dimensions are not associated with worse outcomes when a Carillon indirect annuloplasty is performed. The data show coaptation height and tenting area are predictors of positive outcomes with the Carillon system, and the best responders have a higher baseline tenting area, suggesting perhaps the Carillon system not only decreases the mitral annulus but may also improve mitral annular function, while inducing favorable LV remodeling."
The Carillon system offers a right heart approach to TMVR and is designed to reshape the anatomy and improve 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. The Carillon system received CE Mark approval and is available for use in Europe, Australia, Turkey, and the Middle East. The Carillon system is approved for investigational use in the United States, advised the company.