Apical Access System with Universal Connector for Beating Heart LVAD Implantation

DESCRIPTION provided by applicant The objective of this proposal is to complete development of a long term universal Apical Access System AAS to improve clinical outcomes and expand the role of left ventricular assist device LVAD therapy The treatment of end stage heart failure HF is the greatest challenge both clinically and economically to the U S health care system today With andgt people suffering with end stage HF and only heart transplants and LVADs implanted annually there is large a population underserved LVAD implantation requires a major operative procedure with significant peri and post operative bleeding complications mortality and treatment costs APK Advanced Medical Technologies Inc AAS System will allow current LVADs and future andquot Mini VADsandquot to be implanted suture less through a minimally invasive incision without placing the patient on cardiopulmonary bypass CPB By eliminating CPB reducing access time and reducing bleeding a significant and measurable impact on patient health and procedural cost will be achieved The different components of the AAS System have been tested previously on the bench in FEA computational models and through acute and chronic up to weeks animal experiments with positive results The specific aims of the current proposal are Phase I Aim Complete fabrication of the integrated components for the re designed AAS System and demonstrate feasibility for LVAD therapy in acute bovine model n and human cadaver n Phase II Aim Complete the engineering development and design freeze of the LVAD AAS in compliance with Good Manufacturing Practices GMP specifications for a human implant quality system Aim Demonstrate safety and efficacy of the AAS System by completing risk analysis driven validation and verification testing Testing to include Millio cycle fatigue leakage burst testing in pressurized hearts Finite element analysis of anchoring components sterilization validation and biocompatibility anatomical fit and surgical procedure study human cadaver n and in vivo acute n day n and day n in a chronic bovine model with HM II Thoratec and HVAD HeartWare devices Successful outcomes will be quantified by metrics to include incision size ease of use implantation time blood loss durability fatigue on clinical grade components need for CPB conformance to biocompatibility and sterilization ISO standards and secure connection without air entrainment or leakage Aim Demonstrate long term safety and reliability of the LVAD AAS in day pre GLP n and GLP n chronic bovine model study to support an IDE application for a clinical trial in patients with advanced heart failure receiving LVAD implantation only The successful execution of this SBIR project will lead to development of a new clinical paradigm in the treatment of HF Specifically the AAS will reduce surgical complexity and make LVAD therapy affordable leading to improved patient outcomes and quality of life Ultimately clinical acceptance to treat earlier stage HF patients and expansion into global markets can be achieved APK Advanced Medical Technologies Inc Apical Access System AASandquot with universal connector enables a suture less surgical implantation of left ventricular assist device LVAD on the beating heart via a minimally invasive approach which represents a new clinical paradigm in the treatment of heart failure HF with LVAD therapy The AAS approach will reduce blood loss procedure time patient morbidity and mortality and cost of care that will lead to clinical acceptance in earlier stage HF patients and widespread use in global markets