CardiacAssist, a medical device manufacturer based in Pittsburgh, Pennsylvania, received an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) for a clinical study of its TandemHeart cardiac support technology.
According to a press release by the company, the trial is called the TandemHeart to Reduce Infarct Size Study. The trial will be used to research the efficacy of ventricular unloading for the reduction of infarct size in study participants who have experienced a severe heart attack.
Patients involved in the trial will receive a TandemHeart cardiac assist device or a conventional circulatory therapy device as a control. Both devices will be used to unload a patient’s left ventricle in combination with percutaneous coronary intervention. The company believes that the device will be able to reduce long term patient mortality rates. In addition, the device may be able to reduce repeat hospital visits and usage of implantable cardioverters or defibrillators. By reducing these, it may be possible to decrease patient treatment costs significantly.
John Marous is CEO and president of CardiacAssist. In prepared remarks, he said, "The approval of the pivotal TRIS trial represents a major milestone for our company and the industry.” He continued, "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."
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