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The Intera 3000 HAI Pump has been shown to be MR-Conditional only. The device can be safely used under the following conditions:
- Static magnetic field: 1.5 Tesla or 3 Tesla, only
- Maximum spatial gradient magnetic field: 4,000 G/cm (40 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate: (SAR) of 2.0W/kg
- Maximum gradient slew-rate (SR): 150T/m/s per axis
Exceeding the listed MRI Parameters could result in excessive force or torque, which could lead to patient injury.
No adverse events have been reported related to MRIs in patients with HAI pumps, and the use of MRI remains the standard of care across high-volume, expert centers. Pump patients are often imaged every two months while on treatment to assess for resectability. A continuous scan longer than 15 minutes can result in pump temperature increasing by 6.5°C, thereby temporarily increasing flow rate by 90%. Transiently increased flow of floxuridine is not expected to be associated with increased toxicity. There are no known occurrences of adverse events related to MR compatibility in the history of HAI device use.
Full MRI safety information for the Intera 3000 HAI Pump is available in the Instructions for Use.
For questions regarding the Intera 3000 HAI Pump:
Clinical call line, 1-800-660-2660
Email, HAI-medinfo@bsci.com