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MicroPort® CRM Announces CE Mark Approval of the World’s First MR Conditional Mixed Pacing System with ALIZEA™ pacemaker range1

Clamart, France, 18 April 2025 – MicroPort® CRM, a pioneering company in the field of Cardiac Rhythm Management headquartered in France, proudly announces CE mark approval under the EU Medical Device Regulation (MDR 2017/745) for its MR-Conditional Mixed Pacing System, the first of its kind in the world1. 

This approval marks a significant advancement in patient care, enabling safe MRI scans for pacemaker patients implanted with both ALIZEA™ pacemaker range from MicroPort® CRM and selected MR-conditional third-party leads1. The ALIZEA™, BOREA™, and CELEA™ pacemakers, when combined with these compatible leads constitute a MR-conditional pacing system. 

"We are proud to set a new standard for the industry with the world’s first MR conditional mixed pacing system," said Philippe Wanstok President of MicroPort® CRM. "This innovation empowers physicians with more flexibility in lead selection while ensuring enhanced patients benefit from the proven safety of MRI-compatible systems, no compromises, just progress."

With this unprecedented advancement, MicroPort® CRM is expanding MRI accessibility while maintaining the highest standards of safety, flexibility, and innovation. Supporting Left Bundle Branch Area Pacing (LBBAP), the newly approved system enables patients to benefit from physiological pacing and still safely undergo MRI scans.

ALIZEA™, BOREA™, and CELEA™ pacemakers, equipped with Bluetooth® connectivity, have been designed without compromising on size and battery longevity. Their volume is only 11cc and the projected lifespan is 13 years2 with full feature set on, including remote monitoring. This latest generation also integrates advanced features developed by MicroPort® CRM, including: 

• AutoMRI™, which automatically switches in and out of MRI mode upon detection of the magnetic field, 1.5 or 3 Tesla3. The pacemaker may be pre-programmed up to 10 days in advance of the MRI scan. 

• SafeR™*, a pacing mode preserving natural AV conduction that effectively reduces unnecessary ventricular pacing. It has been clinically proven to reduce the risk of onset of atrial fibrillation4 as well as the risk of heart failure hospitalization and cardiac death5. 

• SAM™*, a Sleep Apnea Monitoring feature which reveals a largely under-diagnosed disease with significant cardiac comorbidities such as atrial fibrillation6 

These devices provide comprehensive heart rhythm management and seamless remote monitoring. With the SmartView Connect™ mobile monitor or SmartView Connect™ App, patients can be followed remotely by healthcare professionals, reducing the need for in-clinic visits and easing the burden on the healthcare system.

About Cardiac Pacemakers 

Cardiac pacemakers are implanted in patients with an abnormally low heart rate (bradycardia), preventing them from leading a normal life. They are implanted under the skin, in the chest area, and are connected to the heart by transvenous leads that conduct electrical impulses to pace the heart and restore a normal heart rhythm. Patients implanted with a pacemaker must be regularly monitored by their cardiologist to ensure that the pacing system is working correctly. 

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 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. Our state-of-the-art products are manufactured in Clamart, France, Saluggia, Italy, and in Santo Domingo, Dominican Republic. 

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

References:

  1. System consisting of a pacemaker and one or more lead(s). Refer to MRI solutions for complete information available online at microportmanuals.com 

  2. SafeR mode ON, assuming 50% atrial pacing and 5% ventricular pacing, 60 min-1, 2,5V, 0,35 ms, 750 ohms, sensors ON, Holter ON, Remote ON. Refer to user manuals available at microportmanuals.com
  3. Microport CRM MRI Solutions Manuals available online at microportmanuals.com
  4. Fauchier L, Boveda S, Moreno J at al. SafeR is associated with a risk reduction of first–onset AF in patients with Atrio ventricular blocks_ result from the ANSWER study. Abstract submitted for Cardiostim 2016
  5. Stockburger M. et al., Long-term clinical effects of ventricular pacing reduction with a changeover mode to minimize ventricular pacing in a general pacemaker population. Eur Heart J. 2015 Jan 14;36(3):151-7
  6. Linz D Et al. Sleep apnea severity and risk of atrial fibrillation: The Variosa-AF study. JACC Clin Electrophysiol. 2019 Jun;5(6):692-701

*The SafeR™ and SAM™ algorithms are exclusively available in ALIZEA and BOREA devices.

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