IDEV recommends that patients register the conditions under which the implant can be scanned safely, listed below, with the MedicAlert Foundation or equivalent organization.

SUPERA® Interwoven Self-Expanding Nitinol Stent System

This device is classified as MR Conditional.

The SUPERA® Interwoven Self-Expanding Nitinol Stent System is indicated for palliative treatment of biliary stricture produced by malignant neoplasms and peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).

CAUTION: This device is not yet approved by the FDA for distribution in the United States for peripheral vascular disease.

Non-clinical testing has demonstrated the SUPERA^® Stent is MR Conditional.  A patient with this stent can be scanned safely, immediately after placement, under the following conditions:

• Static magnetic field of 1.5 or 3.0 Tesla
• Highest spatial gradient magnetic field of 2,500 Gauss/cm or less  (extrapolated value from physical testing at 471 Gauss/cm)
• Maximum MR system reported whole body averaged specific absorption rate (SAR) of
• 2 W/kg for landmarks (i.e. center of RF coil) above the umbilicus or 1 W/kg for landmarks below the umbilicus (for vascular)
• 2 W/kg (for biliary)

for 15 minutes of scanning (per pulse sequence), operating in the Normal Operating Mode (i.e., MR system mode of operation where there is no physiological stress to the patient)

RF Heating

In non-clinical testing and analysis of individual stents and testing of two overlapped stents totaling 270mm in length, the SUPERA^® Stent(s) produced a temperature rise of less than

• 6.5°C (~2.6°C accounting for the cooling effects of blood flow) (for vascular)
• 4.1°C (for biliary)

at a maximum MR system reported whole body averaged specific absorption rate (SAR) of 2 W/kg as assessed by calorimetry, for 15 minutes of MR scanning (per pulse sequence) at both 1.5 Tesla and 3.0 Tesla in an MR scanner (GE Signa whole body coil, model #46-258170G1 for 1.5T; and GE Signa HDx 3T whole body scanner, software version 15/LX/MR (15.0.M4.0910a) for 3.0T).

The effect of heating in the MRI environment for stents with fractures is unknown.

Artifacts