CardioFocus has announced that the Japanese Ministry of Health, Labour and Welfare has approved the HeartLight Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF) in Japan.
The HeartLight System is a visually-guided laser balloon technology for controlled and consistent pulmonary vein isolation treatment of 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, a company with 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,” says 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 Japan Lifeline anticipate a commercial launch of the HeartLight System in the first quarter of 2018, after select medical centres have been trained and national reimbursement is in place. Japan Lifeline 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 utilisation of catheter ablation technologies for AF is increasing at substantial rates,” says Paul A LaViolette, executive chairman of CardioFocus. “It is estimated that more than one million people in Japan suffer from AF and together with our well-established distribution partner, Japan Lifeline, we are excited to bring this clinically-validated treatment to patients in this region.”