Stentless Semilunar Heart Valve Reconstruction

Period of Performance: 07/01/1998 - 06/30/1999


Phase 1 SBIR

Recipient Firm

Cardiomend, LLC
Santa Barbara, CA 93110
Principal Investigator


Worldwide, there is an unmet need for cost-effective treatment of valvular heart disease, especially in third world and lesser developed countries. The long-term objective of this project is to introduce a new and cost-effective paradigm for the treatment of aortic and pulmonic valvular heart disease that relies on valve reconstruction rather than replacement, and which is based on novel geometry, newly designed disposable instruments, and the use of autologous tissue. Surgical reconstruction is performed by an easily learned and reproducible method without stents, leaving the patient with only his or her own tissue and sutures. The concept has been articulated, prototypes have been made, animal experiments performed for proof of concept, regulatory approvals obtained, and patent protection initiated. Prior to clinical use, there are four specific aims to be accomplished: geometric optimization of a new unitary tissue pattern with computer assisted design (CAD) techniques, pulse duplicator and static load testing; development of a device for intraoperative testing of tissue thickness, tensile strength and isotropism; selection of the best method for cutting the tissue intraoperatively; and choosing the best material and manufacturing method for the disposable instruments. PROPOSED COMMERCIAL APPLICATIONS: The combination of an easily learned, reproducible method and inexpensive, disposable instruments for reconstruction of diseased aortic and pulmonic heart valves using lightly tanned autologous pericardium without stents has the potential for answering a worldwide need for more cost-effective treatment of valvular heart disease, thus making such treatment available to a greater patient population.