Cardiotech gets nod to start CardioPass clinical trial in Europe

By Elaine Rigoli

Tampa, Fla., May 10 - CardioTech International, Inc. has received written acknowledgement from its Notified Body in Europe that its clinical trial plan has been accepted.

Following the clinical trial, the analyzed data will be submitted to the Notified Body in support of its CE Mark application, the company said in a news release.

The planned 10-patient clinical trial protocol allows surgeons to intraoperatively decide to use the CardioPass synthetic coronary artery bypass instead of autologous vessels.

CardioTech said it estimates that of the 600,000 coronary bypass operations performed worldwide, about 15% of veins are found to be suboptimal.

Patients will be followed for 90 days and assessed for graft patency and quality-of-life measures, the release said.

CardioTech, located in Wilmington, Mass., is a medical-device company that develops, manufactures and sells products to surgically treat cardiovascular disease.

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