Regulatory approval has been granted in South Korea for the Parachute System (CardioKinetix) by the Korean Ministry of Food and Drug Safety (MFDS).
According to a CardioKinetix release, 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,” says 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.”
