This application addresses broad Challenge Area (04) Clinical Research and Specific Challenge Topic 04-HL-110 Treatment of pulmonary hypertension and right heart failure. The overall objective of this proposed program is the U.S. clinical introduction of the Impella RP system, a percutaneously introduced ventricular assist device (VAD) for treatment of acute right heart failure. The device will be a less traumatic alternative to surgically placed extracorporeal right ventricular assist devices (RVADs), the current standard of care for these patients. The Impella RP system is designed to reduce the workload of the right ventricle and promote cardiac recovery, providing flows of up to 4 lpm and up to 2 weeks of support. The program will comprise pre-clinical design verification and validation testing, regulatory filings to the FDA, and an Investigational Device Exemption (IDE) clinical trial to evaluate safety and effective hemodynamic support. Based upon the success of our proposed program, the next steps would be an application for FDA approval to market the device in the U.S. and preparation for clinical introduction.
Acute right heart failure is a significant clinical problem which often occurs in patients affected by pulmonary embolism, pulmonary hypertension, or heart attack, as well as in patients who have been treated with cardiopulmonary bypass, heart transplantation, or left heart mechanical circulatory support. Right ventricular failure that does not respond to medication is treated with mechanical circulatory support in the form of a right ventricular assist device (RVAD). Current surgically placed RVADs offer potential for rapid recovery, but are highly invasive and are associated with a host of complications including blood clots and bleeding. Therefore, a strong unmet clinical need exists for a minimally invasive and percutaneously placed RVAD that requires only a minimal level of anticoagulation. We estimate that up to 25,000 patients each year could benefit from such a short term RVAD.
