Device Dossier

Ingevity+ Leads - Lead, pacemaker, implantable, endocardial

Device Dossier for Ingevity+ Leads - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III, sponsor Boston…

Intended purpose

Intended for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator. In addition, pacing and sensing in the left bundle branch area is indicated with a single or dual chamber pacemaker as an alternative to the right ventricle.

Functional description

Endocardial pace/sense lead intended for chronic bipolar pacing and sensing in the atrium and/or ventricle. Leads have a IS-1 bipolar to be used in conjunction with a compatible cardiac device. Leads are MR Conditional when connected to Boston Scientific MR Conditional pulse generators. Steroid-eluting upon exposure to body fluids, the steroid elutes from the lead to help reduce tissue inflammation response at the distal electrode.

TGA Public Summary