MicroPort CRM's ENO™ Pacemaker Series Receives NMPA Approval for Full-Body 3.0T MRI Compatibility

Feb 05, 2024 10:38 CST Updated 10:38

MicroPort CRM

Cardiovascular Device Developer

Recently,Minimally Invasive^®Cardiac Rhythm Management (MicroPort^®The new generation of transvenous MRI conditional safe implantable cardiac pacemaker system produced by MicroPort CRMApproved for marketing by the National Medical Products Administration (NMPA),The system consists of the ENO™ series of implantable cardiac pacemakers and Vega™ pacing leads, allowing patients to safely undergo 1.5T/3.0T whole-body Magnetic Resonance Imaging (MRI) scans after implantation.The approval of this series of products in China will bring more advantageous new options to a wide range of patients in the country.

▲ Next-Generation Transvenous MRI-Conditional Safe Implantable Cardiac Pacemaker System

MRI is a widely used examination method in modern medicine and has become the gold standard for diagnosing central nervous system and musculoskeletal-related diseases. It is also a primary tool for diagnosing abdomen, vascular, and tumor-related conditions. Compared with 1.5T, 3.0T MRI offers higher image resolution, providing more precise diagnostic information for clinical treatment decisions and is increasingly becoming the preferred choice for routine imaging examinations in more hospitals. Therefore, there is an urgent demand in actual clinical practice for pacemaker systems compatible with 3.0T MRI.

The ENO™ series pacemakers approved this time include three models of ENO™, TEO™, and OTO™, with a total of six types of single and dual-chamber rate-responsive pacemakers. They have a volume of only 8 cubic centimeters and an expected service life of up to 12 years. The Vega™ pacing lead is available in three different lengths for clinical selection. After patients are implanted with the pacing system composed of the above pacemakers and pacing leads, they will no longer be restricted during MRI scans.

The ENO™ series pacemakers, produced in Europe, not only inherit the features of small size, long lifespan, physiological pacing algorithms, and sleep apnea monitoring technology, but also offer unique AutoMRI™ technology that provides convenience for patients undergoing MRI scans. When the MRI mode is activated, the pacemaker automatically switches to MRI scanning mode upon detecting the magnetic field from the MRI equipment. After leaving the MRI magnetic field environment, it can automatically turn off the MRI scanning mode and restore the previously set pacing parameters. Once this feature is enabled, it allows patients to undergo repeated MRI scans within 10 days without additional medical intervention, thereby reducing the burden on both doctors and patients.

Previously, the CAPRI study was conducted across 29 clinical centers globally, including in China, on the MRI-conditional safe pacing system composed of the ENO™ series pacemakers and Vega™ pacing leads. The aim was to verify the safety of the system before and after MRI scans. The results were published in 2023 in the authoritative journal "European Radiology" in the field of global medical imaging clinical research.The approval of the new generation of transvenous MRI conditional safe pacing system in China will help to enrich the product portfolio of MicroPort CRM.^®MicroPort CRM's product pipeline in the Chinese market provides more options for clinical use and benefits more patients in China.

Source: MicroPort微创

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