Effects of Scuba Diving and Hyperbaric Oxygen Therapy on St. Jude Medical Nanostim™ Leadless Pacemakers
Scuba diving, Hyperbaric oxygen therapy (HBOT), and other activities that increase or decrease pressure gradients, can have an effect on the function of Nanostim™ leadless pacemakers.
St. Jude Medical Nanostim™ leadless pacemakers have been tested to an absolute level of 3 atmospheres (2 atmospheres gauge pressure, or approximately 29 psi, at sea-level) with no effect on device function. These tests showed that, if properly administered, HBOT should not interfere with or cause permanent damage to a device. In addition, St. Jude Medical has not received any reports of a Nanostim™ leadless pacemaker being adversely affected by scuba diving or HBOT.
Exposing St. Jude Medical Nanostim™ leadless pacemakers to pressures greater than that listed below has not yet been evaluated, and may cause hermetic failure, and subsequent circuitry damage or loss of pacing function.
Exposure to absolute pressures of up to 2 atm or the equivalent depth of 33 feet of saltwater (1 atmosphere above ambient sea-level pressure) should not have any effect on the CardioMEMS™ PA Sensor. Pressures beyond 2 atm have not been tested. As the PA Sensor is a diagnostic sensor only, exposure to HBOT pressures greater than 2 atm should be weighed based upon patient need.
If you have any questions on this topic, please contact St. Jude Medical CRM Technical Services.
Effects of Scuba Diving and Hyperbaric Oxygen Therapy on St. Jude Medical Nanostim™ Leadless Pacemakers (269kb)