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AEROPACE SYSTEM INDICATIONS FOR USE
The AeroPace System is indicated to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation – in patients ages 18 years or older on mechanical ventilation ≥ 96 hours and who have not weaned.
SAFETY INFORMATION
Do not use the AeroPace System with active implanted cardiac pacemakers, defibrillators, or other implantable electronics within proximity to the AeroPace Neurostimulation Catheter. The AeroPace System has not been clinically evaluated for safety with these implantable electronic devices.
Risks include those that may occur with the use of central venous catheters and the risks of nerve and diaphragm stimulation. These may include the risks of infection, blood vessel damage, or cardiac effects that can occur with use of catheters. Stimulation risks are rare and may include nerve injury or fatigue of the breathing muscle.
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CAUTION: The AeroNova System is limited by Federal law (United States) to investigational use. Used exclusively for clinical investigations.
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Lungpacer® Medical, AeroPace® System and AeroNova® System are registered trademarks of Lungpacer Medical.