Clamart, France, October 02, 2023 – MicroPort CRM, a pioneering company in the field of Cardiac Rhythm Management, headquartered in France with Global Operations, is pleased to announce the launch of the ULYS™ Implantable Cardioverter Defibrillator (ICDs) and INVICTA™ defibrillation lead in Japan. Both devices are MRI conditional at 1.5T and 3T when implanted as a system.
ULYS™ ICD incorporates advanced technology with low current consumption, resulting in the longest predicted lifespan compared to other ICD devices - up to 8 years longer.¹
ULYS™ 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 MRI examinations³.
The INVICTA™ defibrillation lead continuously detects electrical signals from the right ventricle of the heart and delivers either pacing therapy if the heart rate is too slow or defibrillation shocks in the event of a life-threatening ventricular tachyarrhythmia. Both therapies are controlled by the implantable defibrillator, which analyzes electrical signals in real-time.
INVICTA™ safety and efficacy have been assessed in the Apollo clinical study, demonstrating a 100% implantation success rate and a 97.4% complication-free rate at 3 months for the primary endpoint⁴.
Kengo Kusano M.D., Director, Division of Arrhythmia and Electrophysiology, Department of Cardiovascular Medicine, the National Cerebral and Cardiovascular Center in Osaka, Japan, stated: “Protection against inappropriate shock and exceptional longevity are key elements for ICD patient well-being and safety. MicroPort CRM's expertise in these areas perfectly meets the clinical needs of patients, and it is good that these products can complement the offer on the Japanese market of implantable defibrillators.
Noboru Shimizu, VP of MicroPort CRM Japan, declared: "Approximately 6300 patients receive ICD implants each year in Japan. I am confident that ULYS™ and INVICTA™ will enable us to strengthen our presence in our market. They perfectly complement our range of CRM devices with cutting-edge technology that we make available to doctors and their patients, aiming to provide high-quality therapeutic solutions.”
About Implantable Cardiac Defibrillators (ICDs):
Implantable Cardiac Defibrillators (ICDs) are for use in patients at high risk of sudden cardiac death, continuously monitoring heart rate and helping to regulate fast and potentially life-threatening electrical problems in 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) and ‘back up’ pacing in case of bradycardia (slow heart rate). They also deliver high-energy shocks through the defibrillation lead to restore normal rhythm within seconds when the heart's electrical activity deteriorates into ventricular fibrillation.
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.
¹ 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.
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