Wilmington, Massachusetts - Medical device and materials manufacturer CardioTech International Inc. has gained UK Ministry of Health 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 addition allows a wider range of patients to be included in the tests, the Wilmington-based company said.
"Adding a second graft size for the 10-patient clinical trial offers the surgeons an important new option and a larger potential pool of patients to be reviewed for graft implant eligibility for the trial. We now have two sites for the trial that will be able to have both CardioPass sizes," said CardioTech ceo and president Michael Adams said, in an 8 May announcement.
CardioTech added that approval by the Notified Body for a CE (European Community) Mark would allow the CardioPass graft to be marketed and sold in European Union countries, as well as in other countries worldwide that accept this approval for registration.
CardioPass, a synthetic graft for coronary artery bypass uses, is designed to be used in patients who have aleady undergone repeated procedures or have insufficient native vessels for use in a bypass. 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. ChronoFlex's flexibility enables the graft to pulse as a human vein would as it carries blood to the heart, said CardioTech.
PIC: CardioTech's Wilmington headquarters