French cardiac rhythm management company MicroPort CRM has received approval from the US Food and Drug Administration (FDA) for its new line of next-generation implantable pacemakers Alizea and Celea.
MicroPort CRM also secured approval for the pacemakers’ associated products like the Vega pacing leads, the SmartTouch XT tablet-based programmer, and the SmartView Connect Bluetooth home monitor.
The cardiac rhythm management company, a subsidiary of MicroPort Scientific, said that the latest approved devices are the longest-lasting pacemakers for their size on the market today. Both offer a volume of 11cc and have a projected longevity of 13 years, said the company.
Alizea and Celea have the MicroPort CRM’s proprietary AutoMRI mode designed to boost the safety and quality of life of patients during a magnetic resonance imaging (MRI) examination.
The bluetooth-enabled devices have been approved for usage in 1.5 and 3 Tesla MRI scanners when implanted with the Vega pacing leads.
MicroPort CRM president Benoît Clinchamps said: “MicroPort CRM has always been committed to providing medical devices with the most advanced technology and features to improve patient outcomes and reduce the burden on the healthcare system.
“Alizea and Celea pacemakers, associated with the SmartView Connect home monitor, are a perfect example of our objective to improve the management of healthcare by reducing hospital visits while ensuring continuity of monitoring and follow-up.
“These new pacemakers keep patients connected to their clinical team with secured and streamlined communication.”
According to the cardiac rhythm management firm, the longevity of the pacemakers enhances the standard of care for patients and physicians and lowers costs of healthcare.
Additionally, it saves patients from frequent pacemaker generator changes and associated risks like infections.
The patients receiving Alizea or Celea also get the access to the SmartView Connect home monitor. SmartView Connect is said to automatically transmits reports to the cardiologist on the functioning of the system along with alerts about abnormal rhythms, such as atrial fibrillation.
Last year, the company secured FDA approval for its EasyFinder cardiac electrophysiology diagnostic catheters, and PathBuilder transseptal puncture products.
