Cardiac Dimensions today released results from a trial of its Carillon mitral contour system intended for treating functional mitral regurgitation in patients with heart failure, touting significant reductions in regurgitant volume after implantation.
Results from the trial were presented at the German Society of Cardiology annual congress, the Kirkland, Wash.-based company said.
The percutaneous Carillon device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus.
“The significant acute MR benefit demonstrated in our study, achieved by a device that cinches the mitral apparatus via the coronary sinus without compromising the valve or future treatment options, makes the Carillon System a front-line treatment option for FMR patients,” study co-author and presenter Dr. Stephan Stoebe said in a prepared release.
“Functional mitral regurgitation is associated with increased morbidity and mortality in patients with heart failure. For patients ineligible to receive surgical treatment, interventional techniques represent a new therapy option. The findings we presented confirmed the acute hemodynamic effects of the Carillon device on mitral valve morphology and demonstrated an acute reduction in regurgitant fraction in 83% of patients, as documented by transthoracic echo after device implantation,” study lead Dr. Andreas Hagendorff of the University of Leipzig said in a prepared statement.
The Carillon mitral contour system has had CE Mark approval in the European Union since 2011, the company said.
“We are pleased with the results from the University of Leipzig study validating the immediate impact of the Carillon System on mitral regurgitation for a large percentage of FMR patients. This study adds to the growing body of evidence demonstrating the effectiveness and safety of the Carillon System in two key measurements of FMR – a significant MR reduction and favorable left ventricular remodeling, observed most recently in the REDUCE FMR trial, the first and only randomized, blinded, sham-controlled trial conducted in structural heart,” prez & CEO Greg Casciaro said in a press release.
Last October, Cardiac Dimensions said that it won reimbursement from Germany’s Institute for the Hospital Remuneration System (InEK) for its Carillon mitral contour system.