WILMINGTON, Mass. (May 12, 2008) — CardioTech International Inc. has gained approval to add a 4-mm graft for the clinical trial of its CardioPass proprietary synthetic coronary bypass graft.
Previously, the trial was only approved for a 5-mm graft. The approval by the United Kingdom Ministry of Health allows a wider range of patients to be included in the tests, the medical device and materials manufacturer said.
CardioPass, a synthetic graft for coronary artery bypass uses, is designed to be used in patients who have already undergone repeated procedures or have insufficient native vessels for use in a bypass, CardioTech said. This is important because repeat surgeries account for up to 20 percent of all bypass operations, the company said.
The graft is made from ChronoFlex, a proprietary medical-grade polyurethane, engineered to be pulsatile, biostable, torque-resistant and suturable.
Once implanted, the polymer construction allows it to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact, the firm said.