CardioFocus has 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 atrial fibrillation (AF).
CardioFocus is currently working with its distribution partner for Japan, Japan Lifeline Co, to finalise reimbursement pricing, a process expected to be completed in August. Once reimbursement is finalized, HeartLight X3 will be offered 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 visualisation, 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 AF.