02-02-2015

January 30, 2015, the German Institute for the Hospital Remuneration System (InEK) today announced that the iVAC Intra-Aortic Catheter With Para-Corporal Pump for cardiac support of the left ventricle has received German Neue Untersuchungs und Behandlungsmethoden (NUB) Status 4 approval across 14 leading hospitals in Germany, a decision from German regulators that may positively influence reimbursement from insurance companies for the costs of iVAC procedures.

“This positive reimbursement decision signifies an important step forward toward having iVAC Intra-Aortic Catheter with Para-Corporal Pump incorporated into the German DRG system,” stated Torsten Heilmann, Chief Executive Officer, from the exclusive distributor AVIDAL. “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 commercialization 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 Heart Failure. l was granted under the German Institute for the Hospital Remuneration System (InEK) NUB program for facilitating the introduction of innovative technologies that address underserved patient populations. The NUB program provides therapies with a streamlined path to inclusion in the German DRG system. With a designation of Status 4, the 14 approved hospitals may now request reimbursement from their associated insurance companies to cover the costs of iVAC procedures.