MARLBOROUGH, Mass., Jan. 11, 2021 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that it has expanded its existing French distribution partnership agreement with MicroPort CRM in France to include both Spain and Portugal.
“We are pleased to be represented by MicroPort CRM in France and have been very impressed by MicroPort’s launch of HeartLight® X3,” said Burke T. Barrett, Chief Executive Office & President of CardioFocus. “Based on the success in France, we believe MicroPort will achieve rapid HeartLight X3 adoption in both Spain and Portugal.”
“We are convinced our collaboration in Europe with CardioFocus is a win-win partnership,” said Philippe Wanstok, SVP Global Sales and Marketing at MicroPort CRM. “The HeartLight X3 ablation system is the perfect complement to our MicroPort EP range of catheters and Columbus™ 3D imaging system. Innovation leading to simplifying AFib ablation procedures, while gaining in efficiency, is key to success.”
“The precision of the HeartLight X3’s laser technology is truly remarkable,” said Dr. Jean-Marc Sellal, from the University Hospital of Nancy. “The HeartLight X3 System has become my tool of choice for pulmonary vein isolation in the treatment of atrial fibrillation. It allows the cells responsible for the arrhythmia to be destroyed very effectively while preserving the surrounding atrial tissue.”
More than 33 million patients worldwide suffer from AFib,1 which has been associated with significant symptoms, functional impairment, stroke, cognitive decline, heart failure, and reduced longevity. In Europe alone, it is estimated that the number of patients may rise up to 17 million by 20302.
In 2019, European CE Mark approval for the next-generation HeartLight X3 System was obtained. Extensive clinical studies of the HeartLight System and the new HeartLight X3 System demonstrated that AFib patients can be treated quickly and with excellent procedure time predictability3. During the pivotal confirmatory study of 60 patients, the HeartLight X3 System achieved very rapid pulmonary vein isolation (PVI), in as few as three minutes for a single pulmonary vein.
About the HeartLight System
The HeartLight X3 System is a treatment option for some patients whose Afib is insufficiently controlled with medication4. The HeartLight X3 System is a next-generation AFib ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System. The system performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib. Using direct tissue visualization, titratable laser energy and compliant balloon technology, the HeartLight X3 System offers a unique RAPID mode. This third generation HeartLight X3 System offers a unique RAPID mode, which includes precise motor control that enables uninterrupted, high-speed, circumferential lesion creation under direct visual control of the physician resulting in consistently reduced procedure times5.
About MicroPort CRM
MicroPort CRM is a pioneering company in the field of Cardiac Rhythm Management (CRM), whose world headquarters are in Clamart, France. Through our long-standing expertise in CRM, MicroPort CRM develops, manufactures and markets around the world cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure. MicroPort CRM also distributes the Electrophysiology and Coronary Stents products of the MicroPort group in Europe. For more information, please visit www.microport.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 www.CardioFocus.com.
1 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.
2 Zoni-Berisso, Massimo et al. “Epidemiology of Atrial Fibrillation: European Perspective.” Clinical Epidemiology 6 (2014): 213–220. PMC. Web. 25 July 2017.
3 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).
4 In the United States, the HeartLight System is indicated to treat drug refractory, symptomatic, paroxysmal atrial fibrillation (AFib).
5 Predictability is determined by the standard deviation of the procedure time.
Contact:
Helen Winkler
1-949-606-2008
helen@bentoncommunications.com
SOURCE CardioFocus, Inc.
