MicroPort® CRM Receives CE Mark Approval for NAVIGO™ Left Ventricular Pacing Leads

Clamart, France, 24 December 2021 – MicroPort CRM, a pioneering company in the field of Cardiac Rhythm management, headquartered in France, recently received CE Mark approval under the new Medical Device Regulation (MDR – 2017/745) for its NAVIGO™ 4LV ARC and NAVIGO™ 4LV 2D leads, a new range of left ventricular pacing leads.

NAVIGO™ leads are intended to pace the left ventricle when connected to an implantable cardiac resynchronization device (CRT) in patients with heart failure. They are positioned in the coronary venous system, a highly variable network of veins that drains the myocardium of oxygen-depleted blood.

The NAVIGO™ family consists of a range of quadripolar leads, all of which are to the IS4 standard. The leads have a thin diameter of 4.8F and are available in two shape models, ARC and 2D, as well as in two lengths. This family of leads are designed to fit with the anatomy of the coronary venous system and provide physicians with a variety of options for pacing the left ventricle.

NAVIGO™ pre-shaped leads have been the subject of a pre-market clinical study, Navigator, to assess their safety and efficacy. The study, which was conducted on 218 patients, demonstrated an implantation success rate of 97.2%, and a 98.1% complication-free rate at 3 months.1

“NAVIGO™ leads demonstrated excellent performance during its clinical validation,” said Benoît Clinchamps, President of MicroPort CRM. “In usual practice, the placement of the leads to pace the left ventricle can be very challenging given some coronary venous systems made of very small and tortuous veins. I am convinced that the easy handling and the very good electrical characteristics of NAVIGO™ leads will give physicians complete satisfaction. NAVIGO™ leads are the perfect complement of our CRT offer, after the launch in Europe, in July 2021, of GALI, our latest implantable defibrillator featuring cardiac resynchronization (CRT-D).”

About Cardiac Resynchronization Therapy (CRT)

CRT therapy is indicated in heart failure patients with cardiac desynchronization. The CRT devices are implanted under the skin, in the chest area, and are connected to the heart by three transvenous pacing leads that conduct electrical impulses to pace the heart. The pacing leads are positioned in the right atrium, right ventricle and left ventricle. The electric stimulation of the cardiac chambers triggering their contractions is synchronized in order to restore a better pumping efficiency of the heart. The CRT therapy has been demonstrated to improve survival and quality of life, and to reduce hospitalization in heart failure patients.2

About MicroPort CRM

MicroPort® CRM is a pioneering company in the field of Cardiac Rhythm Management (CRM), and a subsidiary of MicroPort Scientific Corporation (stock code: 00853.HK), with world headquarters in Clamart, near Paris, France. Through its long-standing expertise in CRM, MicroPort® CRM develops, manufactures and markets cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure, globally.

For more information, please refer to www.microport.com

1: Data on file, MicroPort CRM

2: Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002;346:1845–1853.