MRI Information
Patients with our stent grafts can be scanned safely in an MRI system, as long as the following criteria are met
Please refer to section MRI INFORMATION of the MinosTM Instructions for Use.
Non-clinical testing indicates that MinosTM Abdominal Aortic Stent Graft and Delivery System is safe in the following MRI (Magnetic Resonance Imaging) environments:
- Philips Achieva 3.0T TX, magnetic field strength 3-Tesla, cavity diameter=60cm, active shielding, short magnet (magnet length 1.57m), maximum gradient field strength 80mT/m, maximum gradient switching rate 200mT/m/ms, software: Philips DICOM Viewer, version: R2.6Ll-SP1
- Magnetically induced displacement force: the maximum deflection angle is 6.5°, less than 45°, that is, the maximum magnetic displacement force is less than gravity
- Radio frequency induced heating: WSAR=3.7W/kg, the temperature rise caused by stent graft upon 20 minutes scanning is 1.13°c
- Magnetically induced torque: no torque
- Image artifacts: Image quality may be affected by MRI-evaluated development area when it is located at and near the graft
Please refer to section 10.4 of the AorfixTM Instructions for Use.
Non-clinical testing has demonstrated that the AorfixTM Endovascular Stent Graft implants are MR Conditional. Patients can be scanned safely immediately after implantation under the following conditions:
- Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T)
- Maximum spatial gradient field less than or equal to 10 T/m
- Normal Operating Mode: Maximum whole-body specific absorption rate (SAR) of:
- 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 1.5T
- 2.0 W/kg for 15 minutes of scanning in Normal Operating Mode at 3.0T
Please refer to section 4.7 of the Instructions for Use.
Non-clinical testing has demonstrated that the AlturaTM Endovascular Stent Graft are MR Conditional. Patients with this device can be scanned safely in an MR system meeting the following conditions:
- Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T)
- Maximum spatial gradient field less than or equal to 30 T/m (3000 gauss/cm)
- Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
- Under the scan conditions defined above, the AlturaTM Stent Grafts are expected to produce a maximum temperature rise of 6.47°C after 15 minutes of continuous scanning
- In non-clinical testing, the image artifact caused by the device extends approximately 11mm
MeridianTM is a
non-standard version of the AlturaTM Stent Graft device and is for the treatment
of specific patients. It is not CE marked and is supplied on a named-patient
basis only.
Please refer to section 4.7 of the AlturaTM Endovascular Stent Graft
Instructions for Use.
Non-clinical testing has demonstrated that the AlturaTM Stent Graft are MR Conditional. Patients with this device can be scanned safely in an MR system meeting the following conditions:
- Static magnetic field of 1.5 Tesla (1.5T) or 3.0-Tesla (3.0T)
- Maximum spatial gradient field less than or equal to 30 T/m (3000 gauss/cm)
- Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
- Under the scan conditions defined above, the AlturaTM Stent Grafts are expected to produce a maximum temperature rise of 6.47°C after 15 minutes of continuous scanning
- In non-clinical testing, the image artifact caused by the device extends approximately 11mm
Please refer to section MRI INFORMATION section of the HerculesTM Instructions for Use.
Non-clinical studies have shown that, magnetic resonance (MRI) examination can be safely performed immediately after the HerculesTM Thoracic Stent Graft is implanted, when the following conditions are met:
Static Magnetic Field:
- In static magnetic field strength is less than or equal to 3T, the spatial magnetic field gradient is not greater than 720-Gauss/cm
MRI Heating Condition:
- During the 15 minutes of static scanning process; under 1.5T/64MHz, the maximum Specific Absorption Rate (SAR) of the patient’s body is not more than 2.9W/Kg, and the temperature rise produced by a single stent will not exceed 1.8°. Under 3T/128MHz, the maximum Specific Absorption Rate (SAR) of the patient is not more than 2.9W/Kg, and the temperature rise produced by a single stent will not exceed 2.3°
Artifacts Information:
- If the area affected by the magnetic field and the location of the stent are overlapped or approachable, MRI quality will be affected. Therefore, during observing the condition of the HT stent, it is necessary to optimize image parameters of the MRI. Under 3T magnetic field, the artifacts of the HerculesTM Thoracic Stent Graft exceeds about 15mm from the stent lumen
Please refer to section MAGNETIC
RESONANCE IMAGING (MRI) of the CastorTM Instructions for Use.
CastorTM Branched Stent Thoracic
Stent Graft is a custom-made device for the treatment of specific patients.
As such, it is not CE-marked and can be supplied on a named-patient basis only.
Non-clinical test showed that the
MRI results of CastorTM after stent implantation under the following conditions
are as follows:
- In static state, the magnetic field strength is equal to 3T
- The spatial magnetic field gradient is no more than 720 Gauss/cm
- The average whole-body specific absorption rate (W-SAR) does not exceed 2.9W/kg, and the scanning time does not exceed 15 minutes
- In the above conditions, a single CastorTM stent has a deflection angle of 4° and does not produce torsion
- In normal scan pattern, under the condition that W-SAR is 2.9W/kg and the scanning time is 15 minutes, the local temperature rise generated for single CastorTM stent is 2°C. The results do not take into account the cooling effect of blood flow
Artifact information:
If the imaging region of interest is close to or at the stent implantation site during MRI scan, artifacts will have an impact.
