Clamart, France, 21 March, 2024 – MicroPort® CRM, a pioneer in the field of Cardiac Rhythm Management, headquartered in France, announces the first implantation in the United States of the ALIZEA^™ Bluetooth®¹ pacemaker system, a combination of the ALIZEA™ pacemaker generator and VEGA™ pacing leads. The procedure was successfully completed by Doctor Jerry Floro at PIH Health Downey Hospital in Downey, California on Monday, March 18, 2024.

This latest pacemaker offering from MicroPort® CRM provides advanced heart rhythm management features and is equipped with Bluetooth® technology for comprehensive remote monitoring equivalent to an in-person follow-up. The full system consists of the ALIZEA^™ implantable pacemaker used in combination with the VEGA^™ active fixation pacing leads, SmartTouch XT^™ tablet-based programmer, and SmartView Connect^™ Bluetooth® mobile remote monitor.

Doctor Floro commented: “I believe that the remarkable longevity, advanced algorithms, and mobile remote monitoring offered in the Alizea pacemaker system, can play a crucial role in providing clinical benefit, safety, and convenience for patients.”

ALIZEA^™ pacemakers have been designed to provide superior battery longevity without compromising on size. At a projected longevity of 13 years² and a volume of only 11cc, ALIZEA™ is the longest-lasting pacemaker for its size on the market today. This latest generation of pacemakers also includes advanced features developed by MicroPort® CRM:

• AutoMRI^™: ALIZEA^™ protects patients by automatically switching to pre-programmed settings when a patient undergoes an MRI scan. The pacemaker may be pre-programmed up to 10 days in advance of the MRI scan. ALIZEA^™ has been tested to be MRI-conditional in 1.5 or 3 Tesla MRI scanners³.

• SafeR^™: A pacing mode that effectively reduces unnecessary ventricular pacing and has been clinically proven to the reduce the risk of onset of atrial fibrillation⁴ as well as the risk of heart failure hospitalization and cardiac death⁵.

• Dual Sensors: ALIZEA^™ offers a combination of minute ventilation and accelerometer sensors for appropriate heart rate response. The combination of both sensors mimics natural exercise physiology. The device learns the patient’s daily activity levels and can automatically reprogram how rate response is applied accordingly.

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 in turn reducing 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) with global headquarters in Clamart, near Paris, France and an associated company of MicroPort® (MicroPort Scientific Corporation; HKEX: 00853). With over 60 years of expertise and innovations, MicroPort® CRM develops, manufactures and commercializes cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure, globally. These state-of-the-art products are manufactured in Clamart, France, Saluggia, Italy, and in Santo Domingo, Dominican Republic. MicroPort® CRM also distributes MicroPort® solutions in Interventional Cardiology and Electrophysiology in Europe.

More information is available at www.microport.com.

References:

1: Bluetooth is a registered trademark of Bluetooth SIG, Inc

2: Alizea DR, 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 user manuals available at microportmanuals.com.

3: Microport CRM MRI Solutions Manuals available online at microportmanuals.com

4: Thibault B. 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: 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.