CardioKinetix Receives South Korean Regulatory Approval for Parachute System
CardioKinetix has received regulatory approval from South Korea’s Ministry of Food and Drug Safety for its Parachute ventricular partitioning system.
The minimally invasive catheter-based treatment partitions damaged heart muscle following a heart attack from healthy heart tissue to decrease the overall volume of the left ventricle and restore its geometry and function, according to the Menlo Park, Calif., company. The procedure is performed in a catheterization laboratory under limited sedation, CardioKinetix adds.
The device offers a solution for patients whose left ventricle becomes enlarged following a heart attack. The problem can result in diminished cardiac output and lead to heart failure symptoms, including shortness of breath, the company says.
The Parachute system has completed a clinical trial in China and was recently approved in Indonesia. — Michael Cipriano