CardioTech International Inc announced the conclusion of an in vivo study using a novel microporous polyurethane-encapsulated coronary artery stent. This opens a potential market of $3 billion annually in the hotly-contested drug eluting stent field.
Eleven Yorkshire pigs were implanted for 30 days with a microporous stent using CardioTech's proprietary ChronoFlex polyurethane. The microporous encapsulation was achieved by using a proprietary electrostatic technique. At the conclusion of the experiment, the implant sites were evaluated for neointimal area, medial area and percent stenosis at the proximal, middle and distal edge locations. The ChronoFlex polymer showed no signs of causing inflammation, or intimal hyperplasia in the arterial walls.
Dr. Michael Szycher, President and Chief Executive Officer of CardioTech International commented: "This study represents a significant milestone in our effort to eventually develop a drug-eluting stent. Our research suggests that a microporous polyurethane covered stent has considerable advantages over currently available stent coating methods, owing to the tissue ingrowth promoted by our technology, and the higher drug-delivery capacity of the microporous membrane."
Dr. Szycher further stated: "This study shows that our hemocompatible ChronoFlex polyurethane can be used as a suitable covering for stents. The polyurethane serves as a carrier to anti-restenosis drugs, must be totally biocompatible (non reactive) to the delicate coronary artery tissue, and be capable of expanding in unison with the stent during deployment. Very few polymers currently available meet these exacting requirements. Armed with this data, we will now seek a strategic partner to start pre-clinical trials."