MicroPort® CRM Receives Approval in Japan for Alizea™ Bluetooth® Pacemaker

Clamart, France, 13 January 2022 – MicroPort® CRM, a pioneering company in the field of Cardiac Rhythm Management, headquartered in France, recently received PMDA Japanese regulation agency approval for its latest range of implantable pacemakers, Alizea™. The devices are equipped with Bluetooth® technology for streamlined remote monitoring when paired with MicroPort® CRM’s SmartView Connect™ home monitor, already approved in Japan.

Alizea™ pacemakers allow cardiologists to monitor devices remotely. The SmartView Connect™ home monitor is designed to be placed at the patient's bedside to allow for the regular transmission of detailed reports to the cardiologist on the functioning of the pacing system, removing the need for patients to visit the hospital for simple routine examinations, and thus reducing the burden on the healthcare system. Alizea™ pacemakers and the SmartView Connect™ home monitor work together to provide the cardiologist with timely alerts and transmissions triggered by patients when they present symptoms, leading to faster and more efficient patient care.

Noboru Shimizu, VP of MicroPort® CRM Sales Japan, commented, "Around 64,000 patients are implanted with a pacemaker each year in Japan, and coupled with the difficulties that have arisen from the current health crisis, there is a growing need to monitor patients remotely, without them having to travel. Thanks to Alizea™ pacemakers and its SmartView Connect™ monitor, we are positioning ourselves in the Japanese market with the very best in cardiac pacing. I am convinced that this will allow us to strengthen our presence in Japan.”

Alizea™ pacemakers have been designed with no compromise on size and battery longevity. With a volume of only 11cc and projected lifespan of 13 years with full feature set on, including remote monitoring, they will save many patients from experiencing a pacemaker change. As part of a newer generation of pacemakers, the Alizea™ pacemakers also include the more advanced features developed by MicroPort CRM, including:

• AutoMRI™, which automatically protects the patient when they undergo an MRI examination, whether with a 1.5 or 3 Tesla scanner

• SafeR™, a pacing mode reducing unnecessary ventricular pacing that has been proven to prevent onset of atrial fibrillation

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

Benoît Clinchamps, President of MicroPort® CRM, noted, “We successfully launched Alizea™ in Europe in June 2021, and Japan is the second region to benefit from its advanced technological functions. As part of our commitment to improve the lives of as many patients as possible, and to support healthcare professionals in their mission, we will continue to deploy Alizea™ and Smartview Connect™ around the world.”

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 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: 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.