Therapy Areas
MicroPort CRM Receives US FDA Clearance for Alizea and Celea Pacemaker Systems
22 May 2023 - - France-based Cardiac Rhythm Management specialist MicroPort CRM has received FDA approval for its latest range of implantable pacemakers, Alizea and Celea, as well as approval for its associated products the Vega pacing leads, SmartTouch XT tablet-based programmer, and SmartView Connect Bluetooth home monitor, the company said.

This marks a significant achievement for patient care and demonstrates the company's commitment to the United States market.

Alizea and Celea feature the AutoMRI mode, a groundbreaking algorithm invented by MicroPort CRM, that increases patients' safety and quality of life when undergoing an MRI examination.

Patients only need to visit their cardiologist once within ten days before their MRI scan to activate the MRI mode.

Once the mode is programmed, upon entering the MRI field, the pacemaker automatically switches to the MRI mode and following the exam reverts back to its initial settings which significantly improves the workflow for both patients and medical staff.

These devices when implanted with the Vega pacing leads are rated for use in 1.5 and 3 Tesla MRI scanners.

At a volume of only 11cc and a projected longevity of 13 years, Alizea and Celea are the longest-lasting pacemakers for their size on the market today.

This leading innovation improves the standard of care for patients and physicians and reduces healthcare costs.

Greater longevity in pacemakers saves many patients from having to undergo extra pacemaker generator changes and the risk of related complications such as infection.

Patients implanted with Alizea or Celea are provided with the SmartView Connect home monitor, which is placed next to their bed.

The SmartView Connect home monitor interface has been designed to be easy to use for an elderly patient population, providing this age group with greater autonomy and involvement in their medical care.

The monitor automatically and regularly transmits to the cardiologist detailed reports on the functioning of the system, as well as timely alerts about abnormal rhythms, like atrial fibrillation, or alerts triggered by patients when experiencing symptoms.

The approval of Alizea, Celea, and associated products is the latest in a number of FDA approvals for MicroPort in the US Last year, MicroPort's EasyFinder cardiac electrophysiology diagnostic catheters and PathBuilder transseptal puncture products received FDA approvals and will be distributed by the MicroPort CRM organization.

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, and a subsidiary of MicroPort Scientific Corp. (stock code:00853.HK), with world headquarters in France.

MicroPort CRM is dedicated to improving the standard of care by bringing patients and physicians the most advanced cardiac technologies.

Through its long-standing expertise, MicroPort CRM develops, manufactures, and markets in more than 50 countries worldwide cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems, and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure.

Its products are manufactured in France, Italy, and the Dominican Republic.