Clamart, France –April 28– MicroPort CRM, a pioneering company in the field of Cardiac Rhythm management, headquartered in France with global operations, announces it has received CE Mark approval under the new MDR (Medical Device Regulation – 2017/745) for its latest range of implantable pacemakers, AlizeaTM and BoreaTM, as well as for the SmartView ConnectTM home monitor. These devices are equipped with Bluetooth®1 technology for advanced wireless remote monitoring.
"We are very proud to be the first company to affix a CE mark to a range of pacemakers under the new European Medical Device Regulation (MDR)," said Vincent Leveaux, VP Product Development at MicroPort CRM. "TÜV SÜD Product Service GmbH, as the Notified Body, carried out the attestation of conformity under the new regulation and helped us to comply with all applicable regulations. The Declaration of Conformity gives an element of safety to customers in all European markets, as it states that essential requirements to ensure the protection of health have been met in the manufacture and that it is a safe and high quality product."
Alizea™ and Borea™ pacemakers are provided with SmartView Connect™ home monitor which is to be placed at the patient’s bedside. The monitor will allow cardiologists to automatically and regularly receive detailed reports on the functioning of the system, saving patients the need to travel to hospital for a simple routine examination.
“We are committed to continuing technological improvements across our entire line of cardiac rhythm devices to improve patients’ lives and enable physicians to provide even better patient care in the changing healthcare landscape,” said Benoît Clinchamps, President of MicroPort CRM. “Alizea™ and Borea™ pacemakers, associated with SmartView Connect™ home monitor, are perfectly in line with this commitment”.
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
1: Bluetooth is a registered trademark of Bluetooth SIG, Inc