Improved Coronary Artery Bypass Graft of 3 Mm Id

Period of Performance: 09/23/1999 - 03/22/2000

Unknown

Phase 1 SBIR

Recipient Firm

Cardiotech International, Inc.
Woburn, MA 01801
Principal Investigator

Research Topics

Abstract

Atherosclerotic cardiovascular disease is the number one cause of morbidity and mortality in the western world. This may lead to arterial stenosis. When this occurs, the consequences range from gangrene, to stroke to myocardial infarction. At the moment, autologous saphenous veins are the treatment modality of choice in low blow flow vessels such as the coronary arteries. However, in many cases the saphenous vein is either unsuitable or unavailable (due to previous stripping). In such a setting, the need for an artificial prosthesis is vital. Artificial prostheses of 3 mm ID tend to fail in the long term due to anastomotic hyperplasia. We propose to test in canines a compliant, microporous coronary artery bypass graft which has shown a low thrombogenicity profile, as well as high biocompatibility index in European clinical trials. The vascular graft will be fabricated from our patented biodurable polyurethane tradenamed ChronoFlex. The graft will feature two bioresorbable radioactive sleeves to eliminate proximal and distal anastomotic hyperplasia. The graft/sleeve combination will be evaluated in vivo by well-accepted techniques. The universal benefit of this research would be to create a clinically and hyperplasia-resistant coronary artery bypass graft. PROPOSED COMMERCIAL APPLICATIONS: A major market exists for the development of a compliant small vessel prosthesis. Currently, there are no clinically acceptable synthetic small vessel prosthesis (3 mm ID). If such a prosthesis could be used for coronary applications, the synthetic vascular graft market could grow to $750 million annually in the U.S.