MicroPort® CRM Receives CE Mark Approval for INVICTA™ Defibrillation Leads

Clamart, France, 13 July 2022 – MicroPort® CRM, a pioneering company in the field of Cardiac Rhythm management, headquartered in France, has recently received CE Mark approval under the new Medical Device Regulation (MDR – 2017/745) for its INVICTA™ family of defibrillation leads.

INVICTA™ is intended for connection to implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) and is placed into the heart right ventricle via the central veins. Once implanted, INVICTA™ continuously senses electrical signals from the heart and delivers either pacing therapy if it is too slow or defibrillation shocks in the event of a life-threatening ventricular tachyarrhythmia.

With the ULYS™ and EDIS™ MicroPort® CRM ICDs, as well as the GALI™ CRT-Ds and the NAVIGO™ left ventricular leads, INVICTA™ enables 1.5T and 3T MRI-compatible systems.

INVICTA™ safety and efficacy have been assessed in the APOLLO clinical study, which demonstrated an implantation success rate of 100%, and a 97.4% complication-free rate at 3 months for the primary end-point[1].

APOLLO study principal investigator, Dr Pedro Marques of Santa Maria Hospital, Lisbon, commented, "Throughout the study I was able to acquire a good practice of the INVICTA™ lead. Based on my own experience and considering its characteristics and clinical results, INVICTA™ has great properties, whether in terms of handling, fixation and electrical performances. With INVICTA™ I can say that I feel confident, which is essential for a defibrillation lead.”

“Bringing INVICTA™ to the market is a critical and major milestone for MicroPort® CRM,” said Benoît Clinchamps, President of MicroPort® CRM. “With the INVICTA™ approval, we have succeeded in completely renewing our portfolio of ICD and CRT-D devices as well as their associated leads, and now can offer to the industry our most advanced lineup of ICD therapeutic solutions and technologies. We have now unleashed the full potential of our ICD portfolio and look forward to it becoming a significant revenue growth driver and profitability driver for our company.”

About Implantable Cardiac Defibrillators (ICDs)

Implantable Cardiac Defibrillators (ICDs) are for use in patients at high risk of sudden cardiac death, continuously monitoring the heart rate and helping to regulate fast and potentially life-threatening electrical problems with the heart. ICDs are connected to the heart by one or two leads, including a defibrillation lead that passes through the veins. ICDs provide pacing bursts to stop sustained ventricular tachycardia (fast heart rate), as well as ‘back up’ pacing in case of bradycardia (slow heart rate). They also deliver high-energy shocks through the defibrillation lead to restore a normal rhythm within seconds when the electrical activity of the heart deteriorates into ventricular fibrillation.

About Cardiac Resynchronization Therapy (CRT)

CRT therapy is indicated in heart failure patients with cardiac desynchronization. The CRT devices are connected to the heart by three transvenous pacing leads that conduct electrical impulses to pace the heart. The pacing leads are positioned in the right atrium, right ventricle and left ventricle. The electric stimulation of the cardiac chambers triggering their contractions is synchronized in order to restore a better pumping efficiency of the heart. The CRT therapy has been demonstrated to improve survival and quality of life, and to reduce hospitalization in heart failure patients.

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 its long-standing expertise in CRM, MicroPort® CRM develops, manufactures and markets cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure, globally.

For more information, please refer to www.microport.com

[1]: Data on file, MicroPort CRM