Cardiac Dimensions wins German reimbursement for Carillon mitral repair device

Cardiac Dimensions said today that it won reimbursement from Germany’s Institute for the Hospital Remuneration System (InEK) for its Carillon mitral contour system intended to treat patients with functional mitral regurgitation.

The Kirkland, Wash.-based company’s 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 system has had CE Mark approval in the European Union since 2011.

“With this reimbursement in place and following the positive late-breaking clinical data from Reduce FMR presented last month at TCT, we expect to see significant growth in Germany, the largest market in which the Carillon mitral contour system is currently available. We are pleased that this decision means many more people will now benefit from Carillon therapy,” prez & CEO Gregory Casciaro said in a prepared statement.

Cardiac Dimensions said that the InEK granted the company’s Carillon system a permanent Diagnosis Related Group code covering its reimbursement, which is set to go into effect on January 1 next year.

The company said that the system had only been available in limited volumes under the Neue Untersuchungs-und Behandlungsmethoden program, but that the new approval will expand availability to all eligible patients in Germany.

“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,” Dr. Michael Haude of Lukas Krankenhaus Neuss said in a press release.

Last month, Cardiac Dimensions said that a study of its Carillon mitral valve repair device met its primary endpoint, with the data presented at the annual Transcatheter Cardiovascular Therapeutics meeting in San Diego.

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