Device Dossier
Acuity Spiral Lead - Lead, pacemaker, implantable, endocardial
Device Dossier for Acuity Spiral Lead - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III, sponsor Boston…
- GMDN category: Lead, pacemaker, implantable, endocardial
Intended purpose
The Acuity Spiral coronary venous, steroid-eluting, single-electrode pace/sense leads are transvenous leads intended for chronic, left-ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible pulse generator.
Functional description
The Acuity Spiral Lead models 4591, 4592 & 4593 are unipolar, coronary venous pace/sense leads of different lengths (80, 90 & 100cm respectively). These leads are designed for over-the-wire delivery and are designed with an IS-1 unipolar connector. Lead fixation is achieved through a spiral or helical shape in the distal body of the lead.