Clamart, France, 12 May 2025 – MicroPort® CRM, a pioneering company in the field of Cardiac Rhythm Management headquartered in France, proudly announces the first implantation in Japan as part of its international post-market clinical study, PIANO.
The PIANO study is designed to assess the safety and performance of MicroPort CRM's commercially available pacemakers and defibrillators, including Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D), along with their associated leads. This evaluation is conducted in line with the stringent requirements of the European Medical Device Regulation (MDR).
Japan has now become part of this global initiative through a dedicated sub-study centered on CRT-D devices featuring MicroPort CRM’s proprietary SonR® technology. The first patient included in this sub-study was successfully implanted with a GALI™ SonR® CRT-D device at Chiba University Hospital on May 12. Leading the sub-study is Associate Professor Yusuke Kondo, Principal Investigator at Chiba University Hospital who declared:
“We are thrilled to launch the PIANO study in Japan and to strengthen our collaboration with renowned cardiac centers around the world.”
"This milestone reinforces our commitment to advancing cardiac care and validating our upcoming technologies and clinical innovations in real-world settings across diverse patient populations." said Vincent Leveaux, Chief Operating Officer of MicroPort® CRM.
The PIANO study continues to enroll patients internationally, aiming to generate robust clinical data supporting the use of MicroPort® CRM’s devices in compliance with evolving regulatory standards and in pursuit of improved patient outcomes.
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.
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.4
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 our long-standing expertise in CRM, MicroPort® CRM develops, manufactures and markets around the world cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure. Our state-of-the-art products are manufactured in Clamart, France, Saluggia, Italy, and in Santo Domingo, Dominican Republic.
For more information, please refer to 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. 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.