MICROPORT-CRM

MicroPort CRM, a pioneering company in the field of Cardiac Rhythm management, headquartered in France with global operations, announced today the European launch of Alizea^TM and Borea^TM pacemakers after receiving the CE mark under the new Medical Device Regulation (MDR - 2017/745). The devices are equipped with Bluetooth®¹ technology for streamlined remote monitoring when paired with the SmartView Connect^TM home monitor.

Alizea^TM and Borea^TM connected pacemakers allow cardiologists to monitor the devices remotely, saving patients the need to travel to hospital for a simple routine examination and thus reducing burden on the healthcare system. Today, with more than 500 000 patients per year implanted with a pacemaker across Europe, connected cardiac technologies are needed more than ever.

"MicroPort CRM has always been committed to providing medical devices with the most advanced technology and features to improve patient outcomes and reduce the burden on the healthcare system”, said Benoît Clinchamps, President of MicroPort CRM. “Alizea^TM and Borea^TM pacemakers, associated with SmartView Connect^TM home monitor, are a perfect example of our objective to improve the management of healthcare by reducing hospital visits, while ensuring continuity of monitoring and follow-up. These new pacemakers keep patients connected to their clinical team with secured and streamlined communication.”

The devices are provided with a smart home monitor, SmartView Connect^TM , which is to be placed at the patient’s bedside. The monitor allows cardiologists to automatically and regularly receive detailed reports on the functioning of the system, as well as timely alerts and transmissions triggered by the patients when they have symptoms. The SmartView Connect^TM home monitor is equipped with an interface that has been designed to be suitable for an elderly patient population, providing greater autonomy and involvement for this demographic regarding their therapy.

Alizea^TM and Borea^TM with Bluetooth® capability have been designed without compromising on size and battery longevity. Their volume is only 11cc and the projected lifespan is 13 years with full feature set on, including remote monitoring, saving many patients from having to experience a pacemaker change. This newest generation of pacemakers also includes the more advanced features developed by MicroPort CRM, including:

• AutoMRI^TM , which automatically protects the patient when he or she has to undergo an MRI examination, whether with a 1.5 or 3 Tesla scanner³
• SafeR^TM , a pacing mode reducing unnecessary ventricular pacing that has been proven to prevent onset of atrial fibrillation⁴
• SAM^TM , a Sleep Apnea Monitoring feature which reveals a largely under-diagnosed disease with significant cardiac comorbidities such as atrial fibrillation⁵

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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 its 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

1: Bluetooth is a registered trademark of Bluetooth SIG, Inc
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: Thibault B, Ducharme A, Baranchuk A, et al. Very low pacing rates can be achieved safely in a heterogeneous pacemaker population and provide clinical benefits. The Canadian Multi-centre randomized study-spontaneous atrioventricular conduction preservation (CAN-SAVE R) trial. J Am Heart Assoc. 23:4(7), 2015.
5: 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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