Development of a Totally Implanted Left Ventricular Assist Device

Project Summary/Abstract In the United States (US) ~6.5 million people have heart failure (HF), there are ~1 million new cases each year, and ~250,000 patients die of heart failure each year. While a heart transplant is the standard treatment, the limited supply of donor organs severely limits this option. A left ventricular assist device (LVAD) is currently an accepted treatment option for HF patients, however, only ~2-3% of the over 100,000 potential LVAD recipients choose an LVAD each year in the US because of the serious complications and poor quality of life. The percutaneous driveline (permanent skin puncture) and continuously worn external batteries powering the high- power consumption blood pump (~8 W) are major causes of complications and poor quality of life. Complications experienced by LVAD recipients include infection, stroke, bleeding, and pump thrombosis. Infection is a major concern, with up to 44% of LVAD recipients developing an infection. Quality of life restrictions include limited physical activity, inability to submerse in water, and continuously worn external LVAD equipment. Our objective is to develop a Totally-Implanted Left Ventricular Assist Device (TI-LVAD) achieving reduced complications and enhanced patient quality of life to encourage more patients to adopt an LVAD as a bridge-to- transplant, bridge-to-recovery, or destination therapy. The TI-LVAD’s ultra-low-power blood pump, implantable battery, and wireless transcutaneous charging eliminates the percutaneous driveline and will provide patients up to 12 hours of continuous freedom from wearing an external power supply. The key enabling technology of the TI-LVAD is a hybrid magnetically levitated blood pump combining the best features of hydrodynamic bearing and magnetic levitation creating an ultra-low-power and biocompatible blood pump. The TI-LVAD received FDA Breakthrough Device Designation in January 2020. TI-LVAD feasibility has been established by demonstrating ultra-low-power and blood compatible pump operation for up to 30 days in a bovine model. This SBIR Direct to Phase II project aims to finalize the TI-LVAD design and complete all pre-clinical testing. We aim to achieve this by: 1) Developing the implanted controller, external physician programmer, and external hand-held patient monitor, 2) Designing and evaluating the implanted receiver coil and external wireless charger, 3) Performing TI-LVAD bovine testing to assess performance and biocompatibility, and 4) Conducting benchtop durability testing.