CardioFocus Receives Regulatory Approval to Market HeartLight X3 System in Japan

- Japan Lifeline will distribute CardioFocus' innovative catheter ablation technology for pulmonary vein isolation, the gold standard treatment for atrial fibrillation

- Regulatory approval comes as use of catheter ablation technologies for AFib is increasing in Japan at a substantial rate

News provided by

CardioFocus, Inc.

Jun 23, 2021, 09:00 ET

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
The HeartLight X3 System is a revolutionary catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for AFib. Using direct tissue visualization, titratable laser energy and compliant balloon technology, the HeartLight X3 System is a truly differentiated PVI solution. HeartLight is a treatment option for some patients whose AFib is insufficiently controlled with medication.² More than 33 million patients worldwide suffer from AFib³,which has been associated with significant symptoms, functional impairment, stroke, cognitive decline, heart failure, and reduced longevity. The company has obtained approval and is launching the HeartLight X3 System in Europe the U.S and Japan. This technology offers a unique RAPID mode, which leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician. Clinical studies of the HeartLight X3 System demonstrated that AFib patients can be treated quickly resulting in consistently reduced procedure times with excellent procedure time predictability.^4,5

About Japan Lifeline Co., Ltd.
Japan Lifeline is a manufacturer and full-service distributor of medical devices specializing in the cardiovascular space with a track record of about 40 years in Japan. The company's proprietary products developed based on its wealth of experience of arrhythmias and cardiovascular surgery have been highly evaluated, and the company holds a top-class market share in Japan. Japan Lifeline is a publicly traded company, ticker symbol 7575 (TSE 1st Section). Visit the Japan Lifeline website at: http://www.japanlifeline.com.

About CardioFocus, Inc.
Founded in 1990 and headquartered in Marlborough, MA, CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AFib), the most common heart arrhythmia. The HeartLight balloon catheter, endoscope, sheath, console and balloon fill media are all manufactured in the USA. For more information, visit http://www.CardioFocus.com.

Media Relations
Sean Leous
Westwicke/ICR
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^{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.}^{2 In the United States, the HeartLight System is indicated to treat drug refractory, symptomatic, paroxysmal atrial fibrillation (AFib).}^{3 Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.}^{4 Boris Schmidt, Petr Neuzil, et al; Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System; Circ Arrhythm Electrophysiol. 2021;14:e009544. DOI: 10.1161/CIRCEP.120.009544.}^{5 Predictability is determined by the standard deviation of the procedure time.}

SOURCE CardioFocus, Inc.