AXIOS Stent and Delivery System

Conditional

BOSTON SCIENTIFIC CORPORATION

Implantable transenteric drainage tube

The delivery system has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of delivery system in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Non-clinical testing demonstrated that the AXIOS Stent is MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:

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