CardioFocus Expands Partnership With Japan Lifeline

Massachusetts-based CardioFocus, Inc., a developer of endoscopic ablation system for the treatment of cardiac disorders (atrial fibrillation), is expanding partnership with Japan Lifeline Co., Ltd. (JLL), to accelerate their commercialization efforts to the Japanese market.

To support Japanese approval, CardioFocus originally established a distribution partnership with JLL in 2014. Since receiving approval from the Japanese Ministry of Health, Labour and Welfare in July, initial commercial cases have been completed successfully at four hospitals. The companies expect full commercial launch of the HeartLight System to begin in 2018 after national reimbursement is in place.

CardioFocus, Inc. develops HeartLight Endoscopic Ablation System for the treatment of cardiac disorders (atrial fibrillation). Photo: CardioFocus

Under the expanded agreement, CardioFocus and JLL will increase the scope of their Japan and pursue commercialization of the HeartLight System in other Asia Pacific markets.

JLL is also making a substantial financial investment in CardioFocus that will be used to accelerate the market expansion of HeartLight globally and support development of the company's third-generation product, the HeartLight X3 System, which will begin clinical evaluation in Europe during 2018 with prospects of a Japan launch in the future.

The HeartLight System is a visually guided laser balloon technology for controlled and consistent pulmonary vein isolation (PVI) treatment of atrial fibrillation (AF). Its direct visualization, titratable laser energy, and universal balloon design make it a new standard for PVI procedures. It provides an effective and safe treatment option for patients whose heart arrhythmias are insufficiently controlled with medication.

"In Japan, physicians are responding very positively to the HeartLight System," said Keisuke Suzuki, president and chief executive officer of Japan Lifeline. "We are eager to continue the commercial launch and bring this revolutionary new treatment to more AF patients."

"We greatly value this partnership with JLL and the momentum it has created for the HeartLight System in Japan and look forward to offering it in additional Asia Pacific markets," said Paul A. LaViolette, executive chairman of CardioFocus. "This expanded agreement will help CardioFocus achieve its long-term goals as a company committed to leading in the field of PVI."