PercAssist LVAD Technology for healthy independent living for heart disorder.

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PercAssist is developing a percutaneous ventricular assist device (VAD) implanted in an extra-cardiac position for chronic ventricular support. Heart disease remains the leading cause of death according to the Center for Disease Control and Prevention (CDC) and heart failure affects 5.7 million adults in the United States. For end stage heart failure (ESHF), the limited availability of donor hearts for transplantation leaves VADs as the only option for patient survival. However, current VAD implantation is severely limited, due to high device and procedural costs, invasiveness of open chest placement, and complications of thromboembolism, stroke and infection. The goal of this Phase 1 proposal is to show efficacy of a VAD that is placed in a minimally invasive extracardiac fashion and complete fatigue testing of the implant. The specific aims of this proposal are to: (Specific Aim 1) Design and prototype an implantable balloon and catheter that will pass the fatigue and durability testing required for a first in man (FIM) study. The milestone for SA1 is that the Balloon Implant reaches a minimum of 40 million cycles without durability failures. Cardiovascular implants may require 200 million cycles63 prior to device approval, we aim for 40 million cycles with the Phase 1 application as patients are typically on VADs for 2-6 months as bridge to transplants.65 40 million cycles is roughly a year’s worth of durability data at an average heart rate of 70 BPM. Based on experience with prior cardiac implants we believe this will be a sufficient starting point for initiating conversations with the FDA for a FIM trial. (Specific Aim 2) Percutaneously deliver and anchor the Percassist implant in a porcine model and demonstrate substantial continued cardiac output (CO) increase relative to a DCM (direct cardiac massage) baseline. The pre-clinical cadence is defined as follows: 1) Surgically implant balloon into pericardium and synchronize with beating heart. Demonstrate a percentage increase in CO quantitatively measured using an aortic flow probe at the aorta with implant (complete). 2) Identify and sustain CO increase (CO will be quantitatively measured with the device and using DCM) over a min. This ratio will be the quantitative marker for success in Milestones 3 and 5. 3) Sustain CO increase (identified above) with anchoring catheter. Success is defined as meeting the CO identified in Milestone 2 for a minute. 4) Deliver balloon percutaneously and synchronize with beating heart. Success is defined as reaching the pericardial space and delivering the device without surgical intervention. 5) Anchor balloon percutaneously and sustain CO increase (identified above in Milestone 2) over a min. Milestones 1 ,2 and 3 will be supported by outside funding. Milestones 4 and 5 will be directly reported on as part of this application. A future Phase 2/2b will support Verification, Validation and Market release as demonstrated in the development plan below. A more detailed Commercial Plan will be included in a future Phase 2 proposal.