CardiacAssist receives FDA IDE approval for TandemHeart pivotal trial

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Pittsburgh-based medical device maker CardiacAssist received Investigational Device Exemption approval from the FDA to begin a pivotal clinical study of its TandemHeart circulatory support system.

The TandemHeart to Reduce Infarct Size trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients with severe heart attack, according to the press release.

"The approval of the pivotal TRIS trial represents a major milestone for our company and the industry, " president & CEO John Marous said in prepared remarks. "With the completion of our pre-clinical animal studies, which showed a strong correlation between high degrees of ventricular unloading and improved myocardial salvage, we are excited to extend this concept to human trials and hopefully achieve similar clinical benefits."

The patients in the trial will receive either conventional therapy or a TandemHeart device to unload the left ventricle along with percutaneous coronary intervention, the company said.

The device might reduce long term mortality and the rates of repeat hospitalization and implantable cardioverter-defibrillator usage, which could decrease the cost of treatment, according to the press release.

The system last year won clearance from the FDA for use with an oxygenator.

The new trial is expected to begin enrolling patients early next year in up to 20 hospitals, the company said.

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