Medtronic Receives NMPA Approval for Aurora EV-ICD™, a Novel Extravascular Implantable Cardioverter Defibrillator System

Recently, the National Medical Products Administration approved Medtronic's innovative product registration application for an extravascular implantable cardioverter defibrillator.

This product consists of an implantable cardioverter defibrillator and a torque wrench, forming an extravascular implantable cardioverter defibrillation system when combined with extravascular implantable cardiac defibrillation leads. Placed under the sternum, it provides automatic treatment for antitachycardia pacing, cardioversion, and defibrillation in patients at significant risk of experiencing or potentially experiencing life-threatening ventricular tachycardia.

This product has the functions of cardiac and vascular anti-tachycardia pacing and asystole prevention pacing. Compared with the transvenous implantable cardioverter defibrillator system, it can effectively reduce complications related to transvenous leads and better meet patients' clinical needs for magnetic resonance imaging examinations at 1.5T and 3.0T field strengths.

The drug regulatory department will strengthen the post-marketing supervision of the aforementioned products to protect patient safety in medical device use.

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