Cardiac Dimensions announced that the company’s Carillon mitral contour system has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 1 approval across 120 hospitals in Germany, a decision from German regulators that may positively influence reimbursement from insurance companies for the costs of Carillon procedures.
An innovative, minimally-invasive therapy, the Carillon system is designed to treat heart failure patients suffering from functional mitral regurgitation. An estimated 70% of the 20 million people worldwide with heart failure also suffer from functional mitral regurgitation, a press release reports.
“This positive reimbursement decision signifies an important step forward toward having Carillon incorporated into the German DRG system,” says Rick Stewart, chief executive officer. “It is also emblematic of the strong clinician interest we are seeing in Europe and will be the basis for the significant expansion of our commercialisation efforts. We look forward to increasing our collaboration with the German clinical community and broadening the availability of our therapy to additional patients suffering from functional mitral regurgitation.”
According to the press release, the approval was granted under the German Institute for the Hospital Remuneration System NUB programme for facilitating the introduction of innovative technologies that address under-served patient populations. The NUB programme provides therapies with a streamlined path to inclusion in the German DRG system. With a designation of Status 1, the 120 approved hospitals may now request reimbursement from their associated insurance companies to cover the costs of Carillon mitral contour system procedures. Only one other implantable cardiac device had more than 100 hospitals receive this designation for 2014.
The Carillon mitral contour system combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon. Utilising the heart’s natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation, the press release adds.