Aug. 1, 2017 — The Japanese Ministry of Health, Labour and Welfare has granted Japanese market clearance for the CardioFocus HeartLight Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF).
The HeartLight System is a visually guided laser balloon technology for controlled and consistent pulmonary vein isolation (PVI) treatment of atrial fibrillation (AF). It provides an effective and safe treatment option for patients whose heart arrhythmias are insufficiently controlled with medication.
To support Japanese approval, CardioFocus has established a distribution partnership with Japan Lifeline Co., Ltd. (JLL). JLL has a 36-year history as a manufacturer, importer and distributor of quality medical products. Japan Lifeline will sell the HeartLight System through its electrophysiology division, which includes more than 200 field personnel across 44 offices.
"By achieving approval for the HeartLight System in Japan, we are able to continue our long tradition of providing innovative products for the treatment of arrhythmias in Japan," said Keisuke Suzuki, president and CEO of Japan Lifeline. "Our trusted partnership with CardioFocus will allow us to bring this revolutionary and promising treatment option to AF patients as quickly as possible."
CardioFocus and JLL anticipate a commercial launch of the HeartLight System in the first quarter of 2018, after select medical centers have been trained and national reimbursement is in place. JLL will have dedicated personnel in the field, trained on the HeartLight System, to provide sales, marketing and clinical support for the launch.
"Japan is the second largest market for medical technologies in the world and the utilization of catheter ablation technologies for AF is increasing at substantial rates," said Paul A. LaViolette, executive chairman of CardioFocus. "It is estimated that more than 1 million people in Japan suffer from AF and together with our well-established distribution partner, JLL, we are excited to bring this clinically-validated treatment to patients in this region."
Watch the VIDEO “Current State of Atrial Fibrillation Ablation Technologies.” Hugh Calkins, M.D., FACC, FAHA, FHRS, director of cardiac arrhythmia services and professor of medicine at Johns Hopkins Hospital, discusses advancements in AF ablation at the 2017 Heart Rhythm Society (HRS) annual meeting.
For more information: www.cardiofocus.com, www.japanlifeline.com