The broad focus of this project continues to be a response to the unmet need for better and more cost-effective treatment of valvular heart disease. The proposed response to that need, stentless reconstruction of diseased heart valves with autologous tissue, uses methods and instruments being readied for manufacturing and clinical application. Current products and methods are applicable to reconstruction of aortic and pulmonic heart valves. The products consist of a sizer, an intraoperative tissue tester, a cutting device, and a surgical tissue holder, all of which will be made of injection molded thermoplastics and will be packaged and sterilized in disposable kit form.
Specific aims i nclude completion of product development, product manufacturing and sterilization by subcontractors, and initiation of clinical use. Initial clinical use will be limited to a few cardiovascular centers of excellence in the U.S. and Europe until the methods and instruments have been evaluated, and either approved or modified, and reported in the literature. Additional specific aims are development of a compact waterjet tissue cutting device for operating room use, and examination of the feasibility of using the CardioMend principles to reconstruct diseased atrioventricular heart valves, with preservation of the chordal apparatus.
Reconstruction of diseased heart valves with autologous tissue, freely available during cardiac surgery as a sterile non-immunogenic biomaterial, with a reproducible method that does not require a stent or other foreign body, and using inexpensive disposable instruments, constitutes a new treatment paradigm that should have widespread commercial application in both affluent and non-affluent societies.
