NMPA Approves Medtronic's Extravascular ICD Lead and Introducer as Part of 2025’s First Innovative Device Clearance

Apr 17, 2025 17:20 CST Updated 17:20

Medtronic

Chronic Disease Medical Device and Therapy Developer

NMPA today announced the launch of Medtronic's extravascular implantable cardioverter defibrillator leads and extravascular implantable cardioverter defibrillator lead introducers. The advantages of these two products are:With cardiac and vascular anti-tachycardia pacing and asystole prevention pacing functions,Can reduce complications associated with transvenous leads, better meeting the clinical MRI examination needs of patients at 1.5T and 3.0T field strengths.

Product and Usage Composition

The extravascular implantable cardioverter defibrillator lead consists of a lead, a fixation sleeve, and an analyzer cable interface tool. The introducer for the extravascular implantable cardioverter defibrillator lead consists of a substernal introducer and a subcutaneous introducer; the substernal introducer includes a handle, a stainless steel tunneling rod, and an external guiding rod, while the subcutaneous introducer includes a handle and a tunneling rod.

Indications

BloodThe extravascular implantable cardioverter-defibrillator lead and the extravascular implantable cardioverter-defibrillator lead introducer need to be used together, combined with the extravascular implantable cardioverter-defibrillator to form the extravascular implantable cardioverter-defibrillator system, which is placed under the sternum.Automatic treatment for patients at significant risk of life-threatening ventricular tachycardia that has occurred or may occur.。

Currently MedtronicThe extravascular implantable cardioverter defibrillator has not yet been approved for marketing by the NMPA, but it will be soon. In the near future in ChinaPatients with ventricular tachycardia can receive the most advancedDefibrillator Technology Treatment.

EV-ICD

EV ICDIt is an extravascular ICD, whichAimed at treating dangerous rapid heart rhythms that may lead to sudden cardiac arrest (SCA), while avoiding certain risks associated with traditional transvenous ICDs, becauseEV ICDThe leadPlaced outside the heart and veins, below the sternum (breastbone).Placing the lead in this position is intended to help avoid potential issues with the heart and veins.Long-term complications related to leads, such as the risk of vascular occlusion (vein narrowing, blockage, or compression) and blood infections.

EV ICDByDefibrillator andLead Composition, with a size comparable to traditional defibrillators (33 cubic centimeters),GeneralImplanted intoBelow the left armpit (mid-left axilla). This defibrillator, in addition to its function andTraditional ICDSimilar (Defibrillation, Anti-Tachycardia Pacing (ATP), etc.), evenInIn terms of shape and lifespan, similar to traditionalICD AlsoSimilar.The defibrillatorIt can deliver up to 40J of current (half that of Biotronik) and is equipped with sensing and pacing circuits designed for retrosternal treatment.

EV ICDThe lead is ε-shaped, featuring 2 pacing/sensing electrodes and 2 defibrillation coil segments (each 4 cm long), which are tied together for defibrillation purposes to form an 8 cm integrated defibrillation coil. The EV ICD offers 3 sensing and 3 pacing vectors. The sensing vectors include a near-field vector between the 2 ring electrodes and 2 far-field sensing vectors from each ring electrode to the ICD device. The pacing vectors consist of a ring-to-ring vector, a coil-to-coil vector, and a vector from the distal ring to the proximal coil segment.