Japan clears CardioFocus’ HeartLight

CardioFocus said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its HeartLight endoscopic ablation system with an indication for treating paroxysmal atrial fibrillation.

The Marlborough, Mass.-based company’s HeartLight system is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility. The device includes a compliant balloon to accommodate diverse PV anatomies and has a short learning curve to allow for quick adoption of the tech, the company said.

To support the newly cleared device in the region, CardioFocus said it inked a distribution partnership with Japan Lifeline, which will sell the HeartLight system through its electrophysiology division.

“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. Our trusted partnership with CardioFocus will allow us to bring this revolutionary and promising treatment option to AF patients as quickly as possible,” Japan Lifeline prez & CEO Keisuke Suzuki said in a prepared statement.

CardioFocus said it expects to launch the system in Japan during the 1st quarter of 2018 after select medical centers have received training and national reimbursement is established.

“Japan is the 2nd largest market for medical technologies in the world and the utilization of catheter ablation technologies for AF is increasing at substantial rates. 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,” exec chair Paul LaViolette said in a press release.

Last month, CardioFocus said it launched 3 studies of its HeartLight endoscopic ablation system, touting that over 1,000 patients with atrial fibrillation will be enrolled across the studies.

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