CardioFocus today said its HeartLight X3 catheter ablation technology received approval from the Japanese Ministry of Health, Labor and Welfare.
Marlborough, Mass.-based CardioFocus designed the catheter ablation technology for controlled and consistent pulmonary vein isolation to treat atrial fibrillation (AFib).
“MHLW’s regulatory approval for the HeartLight X3 System marks another major milestone for our company as we continue to expand globally,” CardioFocus CEO and president Burke Barrett said in a news release. “We look forward to working with JLL to support their anticipated procedural growth with our third generation HeartLight X3 System.”
The company said it is working with Japan Lifeline to finalize reimbursement pricing and is expected to complete the process in August. Japan Lifeline will distribute the HeartLight X3 to patients in Japan.
“With its direct visualization, titratable laser energy, and compliant balloon design, the HeartLight System has become a new standard for pulmonary vein isolation procedures,” Japan Lifeline president and CEO Keisuke Suzuki said. “Based on physicians’ response in Japan to the first generation HeartLight system, we anticipate rapid adoption of the X3.”