CardioFocus Receives Regulatory Approval to Market HeartLight X3 System in Japan
MARLBOROUGH, Mass., June 23, 2021 /PRNewswire/ -- CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the Japanese Ministry of Health, Labor and Welfare ("MHLW") has approved the company's HeartLight X3 System for marketing in Japan. The HeartLight X3 System is CardioFocus' catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for AFib.
CardioFocus is currently working with Japan Lifeline Co., Ltd. (JLL), its exclusive distribution partner for Japan, to finalize reimbursement pricing, a process expected to be completed in August. Once reimbursement is finalized, JLL will begin offering HeartLight X3 to patients and providers in Japan.
"MHLW's regulatory approval for the HeartLight X3 System marks another major milestone for our company as we continue to expand globally," said Burke T. Barrett, chief executive officer and president of CardioFocus. "We look forward to working with JLL to support their anticipated procedural growth with our third generation HeartLight X3 System."
"With its direct visualization, titratable laser energy, and compliant balloon design, the HeartLight System has become a new standard for pulmonary vein isolation procedures," said Keisuke Suzuki, president and chief executive officer of Japan Lifeline. "Based on physicians' response in Japan to the first generation HeartLight system, we anticipate rapid adoption of the X3."
In 2018, JLL introduced CardioFocus' first-generation HeartLight in Japan. The technology is the world's first ablation system that incorporates laser energy and an endoscope for the ablation treatment of AFib (PVI).
Japan is the second largest market for medical technologies in the world, and the use of catheter ablation technologies for AFib is increasing at a substantial rate. The number of people having AFib in Japan is projected to be over 1 million in the year 2050, which is one fifth of that in the US.1 To support Japanese approval, CardioFocus originally established a distribution partnership with JLL in 2014. Since receiving approval for the original HeartLight System from the Japanese MHLW in 2017, HeartLight utilization in Japan has continued to grow.
About the HeartLight X3 System
About Japan Lifeline Co., Ltd.
About CardioFocus, Inc.
1 Prevalence of atrial fibrillation in the general population of Japan: Analysis based on periodic health examination. Inoue, H. et. al., International Journal of Cardiology 137 (2009) 102–107.
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SOURCE CardioFocus, Inc.