Clamart, France, August 21, 2024 —— MicroPort® CRM, a pioneering company in the field of Cardiac Rhythm management, headquartered in France, announces it has received an expanded labeling for its latest range of implantable pacemakers, ALIZEA™, BOREA™ and CELEA™, for Left Bundle Branch Area Pacing (LBBAP).
LBBAP, utilizing the heart's natural conduction system efficiency, is recognized as the new approach to physiological pacing.1
"Our latest generation of Bluetooth pacemakers integrates our advanced DNA features developed with the support of physicians over the years, always considering physiological behaviors for patients. It now provides the latest feature with Left Bundle Branch Area Pacing (LBBAP), the most recent approach of physiological pacing. This is a first step in the development of our full LBBAP solution", stated Vincent Leveaux, Vice President of Product Development and Operations at MicroPort® CRM.
ALIZEA™, BOREA™, and CELEA™ pacemakers with Bluetooth® capability 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 newest generation of pacemakers also includes the more 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 offer advanced heart rhythm management features and are equipped with Bluetooth® technology for streamlined remote monitoring. With the SmartView Connect™ mobile remote monitor, patients can be followed by their health care professionals remotely, saving patients the need to travel to the clinic for a simple routine check of their pacemaker and reducing burden on the healthcare system.
The current CE mark certificate of ALIZEA™, BOREA™ and CELEA™ Bluetooth pacemakers was obtained in January 2021 and remains valid.
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. Keene D, Anselme F, Burri H, et al. Conduction system pacing, a European survey: insights from clinical practice. Europace. 2023; 25(5): 1-9.
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 Alizea and Borea 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.
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