CardioTech receives approval for a second graft size for CardioPass clinical trial

CardioTech International, Inc., a developer and manufacturer of advanced medical devices and materials for the treatment of a broad range of disease states, today announced that it has received the necessary Ministry of Health approval to add a 4mm graft for the clinical trial of CardioPass , the Company's proprietary synthetic coronary bypass graft. Until now, the trial was only approved for a 5mm graft.

Commenting on today's announcement, CardioTech CEO and President Michael F. Adams 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 for use in the trial. "

Approval by the Notified Body for a CE Mark would allow CardioPass to be marketed and sold in all European Union countries as well as other countries worldwide that accept this approval for registration within those countries.

CardioPass is designed to be an effective alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20 percent of all bypass procedures. CardioPass is made from ChronoFlex, the Company's proprietary biodurable medical-grade polymer and engineered to be pulsatile, biostable, torque-resistant and suturable. Once it is implanted, the graft's 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 has also been specially formulated to be flexible, enabling CardioPass to pulse like a human vein would as it carries blood to the heart.