Effects of Scuba Diving and Hyperbaric Oxygen Therapy on CardioMEMS™ Implantable PA Sensor
Hyperbaric oxygen therapy (HBOT) is a medical procedure in which a pressure chamber is used to deliver 100% oxygen at a level higher than atmospheric pressure. Scuba diving and Hyperbaric oxygen therapy (HBOT) may increase or decrease pressure gradients. Interference with normal device operation of an implanted CardioMEMS™ PA Sensor as a result of scuba diving or HBOT is not anticipated. It is important to note that the CardioMEMS™ PA Sensor provides no therapy to the patient and is a cardiac diagnostic sensor only.
The CardioMEMS™ PA Sensor has been tested to an absolute level of 2 atmospheres (1 atmosphere gauge pressure, or approximately 14.7 psi, at sea-level) for a duration of 48 hours with no effect on device function. The use of HBOT at levels up to this tested limit should not interfere with or cause permanent damage to a device. In addition, St. Jude Medical has not received any reports of a CardioMEMS™ PA Sensor being adversely affected by scuba diving or HBOT.
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 CardioMEMS™ Implantable PA Sensor (103kb)