Medtronic's Transcatheter Leadless Pacemaker System Receives NMPA Approval

On May 12, the National Medical Products Administration (NMPA) announced that, upon review, it has approved the registration application for the innovative product "Transcatheter Implantable Leadless Pacemaker System" produced by Medtronic Inc.

The system is composed of an implantable pulse generator (with fixed wings) and a delivery catheter. It can sense the patient's cardiac activity within the right ventricle, monitor bradycardia rhythms, and provide pacing therapy for bradycardia. This system is a magnetic resonance (MR) conditional safe medical device. Provided that specified conditions are met and special precautions for the patient and the implanted device are ensured, patients can undergo clinical magnetic resonance imaging (MRI) at 1.5T and 3.0T field strengths.

Compared with traditional pacemakers, this system provides atrioventricular synchronous pacing with a single pulse generator implanted in the ventricle, eliminating the need for subcutaneous pockets or transvenous leads connecting to the atrium and ventricle, thereby reducing complications associated with pockets and electrode leads. When using this system, as there is no need to pass pacemaker leads through veins or the tricuspid valve, patients with venous obstruction can also receive pacemaker implants.

This system adds mechanical sensing and atrioventricular synchronous pacing technology on the basis of its predecessor products. It uses a built-in three-axis accelerometer to sense atrial mechanical signals within the ventricle, achieving atrioventricular synchronous pacing. Compared with the existing VVI single-chamber ventricular pacing mode, atrioventricular synchronous pacing can increase the blood volume in the ventricle, thereby increasing the stroke volume with each ventricular contraction, resulting in corresponding clinical benefits.

The mechanical sensing and atrioventricular synchronous pacing technology used in the leadless pacemaker system are both domestic and international firsts.