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news.CardioTech International has received the 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.
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Approval by the notified body for a CE Mark would allow CardioPass to be marketed and sold in all EU countries as well as other countries worldwide that accept this approval for registration within those countries.
Michael Adams, CEO 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.”