CardioTech gets OK to send materials to Europe for trials

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CardioTech International Inc., a maker of biomaterials for medical devices, reports it has garnered U.S. Food and Drug Administration approval to export its 4 millimeter graft material for its clinical trial in Europe.

Wilmington-based CardioTech (AMEX: CTE) said the graft is used in its CardioPass, which is a synthetic coronary bypass graft. The 4 millimeter graft provides a second graft size to use in the clinical trial and enables the firm to complete necessary work to gain a CE Mark to sell CardioPass in European Union countries and outside nations which accept the approval, company officials said.

CardioPass is intended to serve as an option for patients who either lack native tissue for bypass surgery or have had numerous cardiac procedures, according to CardioTech. The firm said 20 percent of bypass surgeries are repeat procedures. The graft is made of a proprietary polymer.

With 22 employees, CardioTech reported a fiscal 2008 net loss of $6.1 million on revenue of $3.2 million.

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