Worldwide, there are more than 800.000 patients suffering from advanced heart failure that would profit from receiving a durable mechanical circulatory support (MCS) device. Yet in the US and Europe, less than 3% of these patients receive any one of the possible treatment strategies per year, i.e.: (a) heart transplantations per year (the current gold standard treatment), due to a chronic organ donor shortage or (b)durable MCS devices. These devices, also referred to as “blood pumps”, are employed restrictively, due to the complications associated with such therapies. Such blood pumps have continuous contact with blood, which can cause blood clotting – thus increase the risk of stroke, and ischemia. To counter this effect, patients are treated with anti-clotting medication, which in turn increases their risk of bleeding. Thus, patients that receive these devices as treatment face potentially severe complications.
reBEAT is a novel, durable MCS device that is developed and manufactured by AdjuCor in Munich, Germany. reBEAT comprises an Implant that can be implanted minimal invasively around a patient’s heart and is connected to an electro-pneumatic Drive Unit that can be carried by the patient. The main differentiation of reBEAT to currently available durable MCS technologies, is that it completely avoids blood contact. Furthermore and contrary to currently available technologies, it can deliver pulsatile support and support one or both sides of the heart.
The objective of this EIC project was to enable the reBEAT technology to reach its final pre-market clinical study and achieve certain key market entry preparatory steps. AdjuCor started with the reBEAT technology development in 2012. Since then, AdjuCor’s multi-disciplinary team was able to achieve key milestones in its development, in vitro and pre-clinical in-vivo tests and regulatory requirements for maturing the technology to reach a sufficient TRL level to qualify for EIC Accelerator funding.
To reach this objective, AdjuCor has been focusing on pre-market activities of preparing for market entry (WP1), performing long-term testing required for different system components, for patient use and for usability (WP2), management of grant (WP3), production of reBEAT systems required for clinical testing and optimization of manufacturing capabilities (WP4) and execution on the world’s, first-in-human study of a device of this kind (WP5).
