The Leadless Pacemaker is indicated for:
Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB),
Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan, or
Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings.
Use of any pacemaker in patients with a co-implanted ICD is contraindicated because high-voltage shocks could damage the pacemaker, and the pacemaker could reduce shock effectiveness.
Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.
Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.
Use of a leadless pacemaker could involve higher levels of risks, compared to those of conventional pacemakers, due to inadvertent pulmonary embolism of the pacemaker in patients also presenting with elevated right-ventricular pressure or reduced pulmonary reserve.
Use in patients with an implanted vena cava filter or mechanical tricuspid valve is contraindicated because of interference between these devices and the delivery system during implantation.
Use is contraindicated in patients who are expected to be hypersensitive to a single dose of 0.7 milligrams of dexamethasone sodium phosphate.
Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.
Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Product referenced is approved for CE Mark.
NanostimTM leadless pacemaker is designed, developed and manufactured by St. Jude Medical.