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CardioKinetix Announces South Korean Approval for the Parachute System for Heart Failure

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CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced that it has received regulatory approval for the Parachute® System in South Korea by the Korean Ministry of Food and Drug Safety (MFDS).

After a heart attack, many patients experience enlargement of their left ventricle causing a decrease in cardiac output resulting in heart failure symptoms such as shortness of breath. Treatment options for patients whose ventricle has enlarged are limited. The Parachute device offers the first minimally invasive catheter-based treatment to partition the damaged muscle, excluding the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

"We are pleased to have received approval for the Parachute device, and are excited to introduce the therapy to patients with heart failure in South Korea," said Maria Sainz, president and CEO of CardioKinetix. "The achievement of this milestone builds upon the technology adoption we are experiencing in the Asia market where we have treated the first 100 patients, completed a Chinese clinical trial, and recently received regulatory approval in Indonesia."

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