Research Project
8713455
DESCRIPTION (provided by applicant): The objective of this proposal is to complete the engineering development and pre-clinical testing of the SCR SVAD system to provide partial cardiac assist in patients with less advanced stage heart failure (HF). HF is increasing worldwide and represents a major burden in terms of health care resources and costs. Despite advances in medical care, prognosis with HF remains poor, especially in advanced stages. Currently, it requires a major operative intervention and cardiopulmonary bypass (CPB), which have been associated with significant adverse event rates and long recovery. The high cost of the intervention and patient follow-up has limited widespread acceptance. The SVAD system consists of a miniaturized axial flow pump (platinum alloy impeller and vane diffuser), inflow cannulation to the left atrium, and outflow graft anastomosis to axillary artery. The SVAD pump (6 cm length, 2 cm diameter, 40 g weight) is implanted through a right lateral mini-thoracotomy. The clinical benefits of the SVAD include: eliminates major surgery (sternotomy), LV apical coring, and aortic anastomosis; performed 'off pump' (no CPB); pump placement in subclavicular pocket facilitates implant (and explant) procedure(s); and superior hydrodynamic performance (5 lpm @ 100 mmHg) with low power requirements. In this phase I-II proposal, we will demonstrate feasibility and complete engineering development and pre- clinical testing of the SVAD to support a FDA submission for phase one (n=10) and phase two (n=300) clinical trials. To achieve this objective, we will complete the engineering development and design freeze of the SVAD system with Good Manufacturing Practices (GMP) specifications for a human implant quality system; demonstrate efficacy and biocompatibility by completing Validation and Verification (V&V) testing (fatigue), anatomical fit and surgical procedure study (human cadaver, n=4), and in vivo acute (n=4), chronic 7-day (n=6), and chronic 45-day (n=8) Good Laboratory Practices (GLP) study. The pre-clinical, V&V, GMP, and GLP study data will be used to support an IDE application for a clinical trial in HF patients. Our long-term goal is to clinically translate the SCR SVAD to treat earlier stage HF patients, using miniaturized partial support device, and less invasive surgical tools and procedures to improve patient outcomes and restore quality of life.
