News | Atrial Fibrillation | August 01, 2017

CardioFocus Laser Endoscopic Ablation System Cleared in Japan

Cardiofocus Heartlight laser ablation system to treat atrial fibrillation (AF).

Aug. 1, 2017 — The Japanese Ministry of Health, Labour and Welfare has granted Japanese market clearance for the CardioFocus HeartLight Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF).

The HeartLight System is a visually guided laser balloon technology for controlled and consistent pulmonary vein isolation (PVI) treatment of atrial fibrillation (AF). It provides an effective and safe treatment option for patients whose heart arrhythmias are insufficiently controlled with medication.

See VIDEO of how the system works in "Editor's Choice of Most Innovative New Technology at HRS 2017."

 

To support Japanese approval, CardioFocus has established a distribution partnership with Japan Lifeline Co., Ltd. (JLL). JLL has a 36-year history as a manufacturer, importer and distributor of quality medical products. Japan Lifeline will sell the HeartLight System through its electrophysiology division, which includes more than 200 field personnel across 44 offices. 

"By achieving approval for the HeartLight System in Japan, we are able to continue our long tradition of providing innovative products for the treatment of arrhythmias in Japan," said Keisuke Suzuki, president and CEO of Japan Lifeline. "Our trusted partnership with CardioFocus will allow us to bring this revolutionary and promising treatment option to AF patients as quickly as possible."

CardioFocus and JLL anticipate a commercial launch of the HeartLight System in the first quarter of 2018, after select medical centers have been trained and national reimbursement is in place. JLL will have dedicated personnel in the field, trained on the HeartLight System, to provide sales, marketing and clinical support for the launch. 

"Japan is the second largest market for medical technologies in the world and the utilization of catheter ablation technologies for AF is increasing at substantial rates," said Paul A. LaViolette, executive chairman of CardioFocus. "It is estimated that more than 1 million people in Japan suffer from AF and together with our well-established distribution partner, JLL, we are excited to bring this clinically-validated treatment to patients in this region."

Watch the VIDEO “Current State of Atrial Fibrillation Ablation Technologies.” Hugh Calkins, M.D., FACC, FAHA, FHRS, director of cardiac arrhythmia services and professor of medicine at Johns Hopkins Hospital, discusses advancements in AF ablation at the 2017 Heart Rhythm Society (HRS) annual meeting.

For more information: www.cardiofocus.com, www.japanlifeline.com

Related Content

Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD
Technology | Implantable Cardioverter Defibrillator (ICD)| September 22, 2017
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab| August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Real-World Analysis Compares Safety, Effectiveness of Apixaban Versus Warfarin
News | Antiplatelet and Anticoagulation Therapies| August 28, 2017
August 28, 2017 — Bristol-Myers Squibb Company and Pfizer Inc.
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
Overlay Init