PaCRTool system - a personalized medicine system for Cardiac Resynchronization Therapy optimization

The overall objective of the SME Instrument project is to mature the PaCRTool system solution for the improvement of CRT efficacy in Heart Failure (HF) patients and to bring it to the market and clinical use. The number of patients with HF is rapidly increasing throughout the industrialized countries with great impact on social and economic resources. The introduction of CRT devices for HF management improved remarkably clinical symptoms, decreased HF hospitalization, all-cause mortality, and reduced overall health care costs. However, despite its success, one third of CRT recipients do not obtain clinical benefit from the procedure. Multiple reasons for such a substantial use non-responder rate have been proposed, with the most important being the positioning of the left heart chamber lead. Thus, there is an urgent unmet medical need for a solution that helps maximizing the efficacy of CRT implantations, the understanding of CRT non-response, and to ensure a proper selection of patients that will undergo CRT. PaCRTool consists in an all-in-one hardware and software system that will change the way CRT implantations are performed. We have designed a unique (patent pending) platform that can guide in real-time the placement of lead electrodes as well as detect non-responders to CRT, avoiding unnecessary burden to the patient and health services costs of implantations. In the SME Instrument Phase 1, we aim to define in more detail our exploitation strategy and market entry to position PaCRTool as the new standard of care for device-based HF treatment. We will engage with stakeholders along the value chain (cardiology KOLs, possible partner companies, end-users, etc.) to define needs and requirements, as well as validate our preliminary business models and the willingness to pay for our solution. Moreover, we also intend to outline a clinical and regulatory strategy for upcoming randomized clinical trials, needed to demonstrate the efficacy of PaCRTool.