HeartLight® X3 Japan Launch Anticipated in Mid-2021
MARLBOROUGH, Mass., Feb. 2, 2021 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatments for atrial fibrillation (AFib), announced today that it has expanded its existing partnership agreement with Japan Lifeline Co., Ltd. (JLL). The agreement extends the timeframe of the existing distribution agreement for Japan, as well as South Korea and Taiwan. The updated partnership also results in JLL taking an equity position in CardioFocus.
“We have partnered with JLL in Japan for many years and have seen great success with the HeartLight® Endoscopic Ablation System there,” said Burke T. Barrett, chief executive officer and president of CardioFocus. “We anticipate the next generation of the device, the HeartLight X3 System, will achieve rapid adoption in Japan when it launches later this year.”
“In Japan, physicians have responded very positively to the first generation HeartLight System,” said Keisuke Suzuki, president and chief executive officer of Japan Lifeline. “We are eager to launch HeartLight X3 and bring this revolutionary and highly efficient new treatment to more AFib patients.”
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. It is estimated that 78,000 people in Japan had an Afib ablation in 20201. 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 Ministry of Health, Labour and Welfare 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 medication2. 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 and the U.S. 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.
1 Inoue, et. al., Int J Cardiol, 2009; 137: 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 X3 total procedure time was statistically significantly shorter than the original HeartLight and irrigated radiofrequency ablation (RF) ablation based on a comparison to the original HeartLight pivotal study (historical control).
5 Predictability is determined by the standard deviation of the procedure time.
CONTACT: Helen Winkler, helen@bentoncommunications.com, 949-606-2008
SOURCE CardioFocus, Inc.
