Device Dossier

Tendril STS Lead Model 2088TC - Lead, pacemaker, implantable, endocardial

Device Dossier for Tendril STS Lead Model 2088TC - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III,…

Intended purpose

The Tendril STS 2088TC lead is designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device. Active leads such as Tendril STS Model 2088TC leads may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial application, te use of a screw-in lead such as Tendril STS Model 2088TC leads may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.

Functional description

The Tendril STS 2088TC lead is a bipolar, steroid-eluting, active fixation implantable pacing lead with Optim insulation. The Tendril STS 2088TC lead can be placed in either the right atrium or the right ventricle. It is packaged with one radiopaque suture sleeve attached to lead,vein lifter,2 clip-on tools,tip retainer, stainless steel stylets with knob colors designating degree of firmness.

TGA Public Summary