Feasibility Testing of Miniaturized Ventricular Assist Device (MVAD)
DESCRIPTION (provided by applicant): The REMATCH trial demonstrated that end-stage heart failure patients supported by a left ventricular assist device (LVAD) provided better patient outcomes than optimal medical management therapy. Despite significant improvements in pump design, performance, and reliability that save lives and restores quality of life, physicians are reluctant to refer patients in less advanced stages of heart failure for LVAD technology. HeartWare (Miami Lakes, FL) is developing a miniature ventricular assist device (MVAD) that may be implanted less invasively and 'off-pump' to treat larger target population of HF patients. The HeartWare MVAD is an axial flow blood pump that uses a 'wide blade' impeller with dual hydrodynamic bearings oneach blade to deliver up to 6 L/m flow. The device consists of an anchor section that is attached to the external surface of the myocardium near the apex, a standpipe that carries the drive cables external to the left ventricle and holds the pump housing off of the internal myocardial surface, a pump housing that contains the MVAD core assembly and a vane diffuser, and a outflow cannula that crosses the aortic valve The clinical benefits of this approach include the opportunity to treat patients with less advanced HF, improved patient outcomes, shorter recovery times, and lower hospital costs. The objective of this proposal is to develop minimally invasive surgical procedure and complete feasibility testing of the HeartWare MVAD. In Specific Aim 1, we will complete feasibility testing of the HeartWare MVAD in acute and 30-day chronic large animal models to assess device performance and hemocompatability, and evaluate anatomical fit and develop surgical procedures in human cadavers. The proposed feasibility testing studies will be conducted at the Cardiovascular Innovation Institute (CII) at the University of Louisville (UofL). If successful, in Phase 2 we will complete development of the HeartWare MVAD and perform long-term GLP animal implants in preparation of an FDA submission for clinical trials. ) PUBLIC HEALTH RELEVANCE: HeartWare (Miami Lakes, FL) is developing a miniature ventricular assist device (MVAD) that can be implanted 'off pump' and using a less invasive surgical procedure. The clinical benefits of the HeartWare MVAD include the opportunity to treat patients with less advanced HF, improved patient outcomes, shorter recovery times, and lower hospital costs.
Small Business Information at Submission:
14000 NW 57TH CT MIAMI LAKES, FL 33014-3105
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