MicroPort® CRM receives MRI-conditional CE mark for Ulys™ and Edis™ ICDs as well as for Gali™ CRT-Ds

Clamart, France, 27 April 2022 – MicroPort® CRM, a pioneering company in the field of Cardiac Rhythm Management, recently received CE Mark approval under the new Medical Device Regulation (MDR – 2017/745) for MRI conditionality on Ulys™ and Edis™ Implantable Cardiac Defibrillators (ICDs), as well on Gali™ and Gali SonR™ devices indicated for Cardiac Resynchronization Therapy and Defibrillation (CRT-Ds).

As of today, all eligible Ulys™, Edis™, and Gali™ devices, including those released before the MRI conditionality approval, and in particular those implanted in the Apollo clinical study with the Invicta defibrillation lead, are becoming MRI-conditional with 1.5 and 3 Tesla scanners.

These devices all feature AutoMR™, a function which detects the presence of an MRI scanner and automatically switches the device into a specific mode that protects patients when they undergo an MRI examination.1

Benoît Clinchamps, President of MicroPort® CRM, stated, “MicroPort® CRM is committed to developing technologically advanced devices that are both lifesaving and beneficial to physicians and patients alike. With that commitment in mind, we have endeavored to make Ulys™, Edis™ and Gali™ MRI conditionality retro-active on eligible configurations. It is a great satisfaction to have achieved this.”

MicroPort® CRM ICD and CRT-D high-voltage devices incorporate advanced technology with low current consumption, resulting in the longest predicted lifespan when compared to other devices - up to 8 years longer for ICD and 5 years longer for CRT-D devices.2

Gali SonR™ uses a unique sensor that measures the contractility of the left ventricle, which allows for resynchronization therapy to be continuously adapted to the individual needs of each patient. The clinically proven SonR™ algorithm has demonstrated a 35% risk reduction in heart failure hospitalization.3 Furthermore, dual-chamber Ulys™ and Gali™ ICDs, as well as Gali™ CRT-Ds, feature PARAD+™ arrhythmia discrimination algorithm, providing the lowest rate of inappropriate shocks ever reported.4

About Implantable Cardiac Defibrillators (ICDs)

Implantable Cardiac Defibrillators (ICDs) are for use in patients with a 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: Microport CRM MRI Solutions Manuals available online at microportmanuals.com
2: Munawar D.A., et al. Predicted longevity of contemporary cardiac implantable electronic devices: A call for industry-wide « standardized » reporting. Heart Rhythm 2018;15(12):1756-63.
3: Brugada J., et al. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial. Eur. Heart J 2017; 38(10):730-8
4: Ruiz-Granell R., et al. Algorithm-based reduction of inappropriate defibrillator shock: results of the Inappropriate Shock Reduction with PARAD+ Rhythm Discrimination-Implantable Cardioverter Defibrillator Study. Heart Rhythm 2019; 16(9):1429-35.