Clamart, France, February 12, 2024 – MicroPort® CRM, a pioneering company in the field of Cardiac Rhythm Management, headquartered in France, is pleased to announce the launch of the GALI™ SonR® Cardiac Resynchronization Therapy and Defibrillation device (CRT-D) and NAVIGO™ 4LV left ventricular pacing leads in Japan.
GALI™ SonR® CRT-D uses a unique hemodynamic sensor measuring the contractility of the left ventricle. The SonR® system is the first and only CRT hemodynamic sensor designed to automatically optimize patients every week and, more importantly, while the patient is active, providing real-life optimization. The clinically proven SonR® algorithm has demonstrated a 35% risk reduction in heart failure hospitalization.1
GALI™ SonR® CRT-D also features the PARAD+™ arrhythmia discrimination algorithm with the clinically proven lowest rate of inappropriate shocks², and AutoMRI™, a function that automatically switches the device into a specific mode to protect patients during Magnetic Resonance Imaging (MRI) examinations³. Additionally, patients implanted with this system are either eligible for 1.5 Tesla (T) or 3T MRI scans, if needed.
The NAVIGO™ 4LV family consists of a range of quadripolar leads, all complying with the IS4 standard. They feature a thin 4.8F lead body, are available in two shape models (Navigo™ 4LV ARC/Navigo™ 4LV 2D) and two available lengths (78cm/88cm). Specifically designed to accommodate the anatomy of the coronary venous system, this lead family offers physicians a diverse range of options for left ventricle pacing.
NAVIGO™ 4LV pre-shaped leads underwent evaluation in a pre-market clinical study called “Navigator” to assess their safety and efficacy. The study, involving 218 patients, demonstrated an implantation success rate of 97.2%, and a 98.1% complication-free rate at 3 months.4
Kengo Kusano M.D., Director, Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine, the National Cerebral and Cardiovascular Center in Osaka, Japan, stated: “Around 3,700 patients in Japan are implanted by a CRT-D device annually. I am confident that MicroPort® CRM CRT-D system integrating cutting-edge algorithms with exceptional longevity, will contribute to ensuring the well-being and safety of our CRT-D patients”.
“I am very impressed with the SonR technology. The use of a contractility sensor at the tip of the SonRtip™ lead to automatically optimize cardiac resynchronization parameters, at rest and during exercise, is a very appealing solution. It is unique on the market, and its effectiveness is supported by solid clinical evidence.” said Professor Morio Shoda M.D., Ph.D., Director and Professor, Clinical Research Division for Heart Rhythm Management, from Tokyo Women’s Medical University.
About Cardiac Resynchronization Therapy (CRT)
CRT therapy is indicated in heart failure patients with cardiac desynchronization. The CRT devices are implanted under the skin, in the chest area, and 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.5
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. Drawing on its extensive expertise in CRM, MicroPort® CRM develops, manufactures, and markets cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems, and ECG diagnostic solutions for managing cardiac rhythm disorders and heart failure globally.
For more information, please visit www.microport.com.
References:
1. 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
2. Dichtl W. et al., Low rates of inappropriate shocks in contemporary real-world implantable cardioverter defibrillator patients: the CARAT observational study. EP Europace, Volume 25, Issue 9, September 2023, euad186, https://doi.org/10.1093/europace/euad186
3. MicroPort CRM MRI Solutions Manuals available online at microportmanuals.com
4. Data on file, MicroPort CRM
5. Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002;346:1845–1853.