Intraventricular Cardiac Assist System for Decompression and Recovery
Department of Health and Human Services
Agency Tracking Number:
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Small Business Information
ABIOMED, INC., 22 CHERRY HILL DRIVE, DANVERS, MA, 01923
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): The overall objective of this proposed program is the commercialization of an advanced intraventricular cardiac assist system for cardiac unloading and recovery. This type of ventricular assist device (VAD) will provide the optimal support for recovery for acute heart failure patients, and may be useful for a select group of chronic heart failure patients supported on VADs. Phase I of the program will demonstrate the feasibility of an innovative VAD system designed to permit rapid insertion and to provide hemodynamic tunability for optimizing ventricular recovery. Key design milestones will include prototype construction, in vitro characterization and in vivo feasibility testing. Following the successful completion of the Phase I studies, Phase 2 of the program will focus on further developing the system for extended use and characterizing its use for ventricular recovery. The Phase 2 results will permit a timely commercial introduction of this technology. This device's ability to tailor support from complete decompression, to gradual reloading, and finally to normalization of the myocyte stress environment will provide heart failure patients the best chance for cardiac recovery. PUBLIC HEALTH RELEVANCE: A growing trend in mechanical circulatory support is the application of ventricular assist devices (VADs) to bridge-to-recovery (BTR), where the goal is to recover the native heart. LVADs provide profound LV volume and pressure unloading while simultaneously restoring both coronary and systemic blood flow. In cases of acute heart failure, it is frequently observed that the rested but well perfused myocardium experiences healing and ultimately a restoration of function. As a result, a strong clinical need exists for a VAD that is easy to implant and tunable to optimize the hemodynamic conditions for recovery. The innovative VAD system proposed here will permit a rapid insertion along with hemodynamic tunabilty to optimize the conditions for recovery. With the proposed device, patients will have mechanical support tailored to their evolving needs: complete decompression early on, then gradual reloading of the heart, and finally normalization of the myocyte stress environment after cardiac recovery. The proposed system would be directly applicable to acute heart failure patients (e.g. those suffering from cardiogenic shock subsequent to acute myocardial infarction, myocarditis, or open heart surgery), which includes approximately 100,000 patients per year in the U.S. It may also promote myocardial recovery in those chronic heart failure patients who require VAD support.
* information listed above is at the time of submission.