The Nanostim™ 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.
The leadless pacemaker is contraindicated for use in patients with pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure > 40 mmHg or RV systolic pressure > 40 mmHg) or significant physiologically-impairing lung disease.
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.
Do not implant an additional Nanostim™ leadless pacemaker in the presence of an implanted Nanostim™ leadless pacemaker, because this has not been tested. Do not implant the device in the presence of an implanted transvenous lead, because this has not been
Do not put excessive forward pressure on the protective sleeve or the delivery catheter when implanting the device, because perforation may result. Do not turn the device more than 1.25 turns during implantation, because perforation may result. Careful consideration should be given to patients who have had cardiovascular or peripheral vascular surgery/intervention within the last 30 days because these patients may have a higher risk of complications.
Implant of a Nanostim™ leadless pacemaker should not be attempted in the presence of an active perforation. Implant sites where a previous clinical event such as perforation or lead extraction with myocardial tissue removal should be avoided as this may result in a higher rate of perforation.
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.