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News

CardioTech to export 4mm graft to support European clinical trial of CardioPass

CardioTech International : 14 July, 2008  (New Product)
CardioTech International has received US FDA approval to export its 4mm graft in further support of the ongoing European clinical trial of CardioPass, the company’s proprietary synthetic coronary bypass graft.
Michael Adams, chief executive officer and president, said, “We are pleased with the FDA’s timely review and approval of our request to export the 4mm Graft for use in our CardioPass European clinical trial. This important milestone provides a second Graft size available for use in the trial and expands the potential patient population available for treatment. In concert with our team of clinical and regulatory professionals in Europe, we believe we are now poised to move towards the completion of our clinical 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.
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