FlexTip Plus Epidural Catheter and the StimuCath Continuous Peripheral Nerve Block Catheter

Teleflex Medical

MRI Information
The FlexTip Plus Epidural Catheter and the StimuCath Continuous Peripheral Nerve Block Catheter were determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International.

Non-clinical testing demonstrated that the FlexTip Plus Epidural Catheter and the StimuCath Continuous Peripheral Nerve Block Catheter are MR Conditional. A patient with each particular device can be scanned safely immediately after placement under the following conditions:

-Static magnetic field of 3-Tesla or less

-Maximum spatial gradient magnetic field of 720-Gauss/cm

-Use of a transmit/receive head RF coil, ONLY, at 1.5-Tesla or 3-Tesla,ONLY

Magnetic Field Interactions: While the FlexTip Plus Epidural Catheter and the StimuCath Continuous Peripheral Nerve Block Catheter displayed relatively high magnetic field interactions during in vivo testing, it should be noted that these devices are maintained in place by means of suture material and bandages/tape and, as such, sufficient counter-forces are present that will prevent movement or dislodgement of the FlexTip Plus Epidural Catheter and the StimuCath Continuous Peripheral Nerve Block Catheter in situ. Therefore, during the intended in vivo use of the FlexTip Plus Epidural Catheter and the StimuCath Continuous Peripheral Nerve Block Catheter, these devices will not present an additional risk or hazard to a patient in the 3-Tesla or less MRI environment with regard to translational attraction or torque.

MRI-Related Heating: In consideration of the position of each catheter and the use of a transmit/receive head RF coil, little if any MRI-related heating occurs because the RF energy is contained within the area of the transmit/receive RF head coil, far away from the position of each device when implanted according to its intended in vivo use. Therefore, there are no MRI-related heating issues for the FlexTip Plus Epidural Catheter and the StimuCath Continuous Peripheral Nerve Block Catheter when using the transmit/receive head RF coil at 1.5-Tesla and 3-Tesla.

Warnings: MRI-related heating associated with the use of other transmit RF coils when a FlexTip Plus Epidural Catheter or the StimuCath Continuous Peripheral Nerve Block Catheter is present in a patient is unknown and, therefore, not advised. Serious injury may occur.

Artifacts: Since the overall findings for the MRI tests for the FlexTip Plus Epidural Catheter and the StimuCath Continuous Peripheral Nerve Block Catheter support the use of the transmit/receive head RF coil at 1.5 and 3-Tesla, ONLY, the size of the artifacts are unimportant since they will not impact the diagnostic use of MRI as it is utilized for diagnostic MRI examinations using the transmit/receive head RF coil.