Biomedical Catalyst – Demonstration of a low cost implantable blood pump

晚期心力衰竭是一个巨大且不断增长的医疗保健挑战，传统的医疗管理、心脏移植或移植无法充分满足。心室辅助装置（VAD）可以满足这一需求，并已显示出非常有前途的临床结果。然而，现有的VAD是昂贵的，由于严重的并发症而具有高使用成本，并且需要广泛的侵入性手术来植入。Calon的MiniVAD通过更小的泵解决了这些问题，减少了血液损伤，显著改善了健康经济学。本项目拟开发新型血液损伤试验，并对MiniVAD进行后续详细的体外和体内评价，以提供支持监管申请所需的性能和安全性数据，从而开始人体临床研究。

Advanced heart failure is a large and growing healthcare challenge not adequately met by traditional medical management, cardiac resynchronisation or transplantation. Ventricular assist devices (VADs) can address this need and have shown very promising clinical results. However, existing VADs are expensive, have high utilisation costs due to significant complications and require extensive invasive surgery for implantation. Calon’s MiniVAD addresses these problems with a smaller pump, reduced blood damage and significantly improved health economics. This project proposes the development of novel blood damage assays and the subsequent detailed in-vitro and in-vivo evaluation of the MiniVAD to provide the performance and safety data necessary to support a regulatory application to begin human clinical studies.