Approval

Japanese PMDA Approves MicroPort CRM’s Alizea Bluetooth Pacemaker

January 19,2022 10:44 AM
- By Admin

MicroPort CRM, a pioneering company in the field of cardiac rhythm management, 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.”

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.

MicroPort CRM is a pioneering company in the field of cardiac rhythm management (CRM), and a subsidiary of MicroPort Scientific Corporation, with world headquarters in Clamart, near Paris, France