H.I.G. Capital News

CardioFocus® Annouces Expanded Distribution Partnership with Microport™ CRM to Include Spain and Portugal

MARLBOROUGH, MA – January 11, 2021 – CardioFocus, Inc., a medical device company dedicated to advancing ablationtreatment for atrial fibrillation (AFib), announced today that it has expanded its existing French distribution partnershipagreement 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 ofHeartLight® 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, SVPGlobal Sales and Marketing at MicroPort CRM. “The HeartLight X3 ablation system is the perfect complement to ourMicroPort EP range of  catheters and  Columbus™ 3D imaging system. Innovation leading to simplifying AFib ablationprocedures, 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 atrialfibrillation. It allows the cells responsible for the arrhythmia to be destroyed very effectively while preserving the surrounding atrialtissue.”

More than 33 million patients worldwide suffer from AFib,1 which has been associated with significant symptoms, functionalimpairment, stroke, cognitive decline, heart failure, and reduced longevity. In Europe alone, it is estimated that the number ofpatients 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 ofthe HeartLight System and the new HeartLight X3 System demonstrated that AFib patients can be treated quickly and withexcellent 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 singlepulmonary vein.

About the HeartLight System
The HeartLight X3 System is a treatment option for some patients whose Afib is insufficiently controlled with medication4. TheHeartLight 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 tissueto block the abnormal electrical pathways that cause AFib. Using direct tissue visualization, titratable laser energy and compliantballoon technology, the HeartLight X3 System offers a unique RAPID mode. This third generation HeartLight X3 System offers aunique RAPID mode, which includes precise motor control that enables uninterrupted, high-speed, circumferential lesion creationunder 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 theworld cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions forthe management of cardiac rhythm disorders and heart failure. MicroPort CRM also distributes the Electrophysiology and CoronaryStents 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 manufacturerdedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AFib), the most common heartarrhythmia. 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 2010Study. 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.