GDC Detachable Coils, GDC 360o Detachable Coils, Matrix2 Detachable Coils, and Target Detachable Coils

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David Wilkerson
6 years ago
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1 GDC Detachable Coils, GDC 0o Detachable Coils, Matrix Detachable Coils, and Target Detachable Coils Magnetic Resonance Imagining (MRI) Compatibility (Neurovascular Use) Non-clinical testing and analysis have demonstrated that when used in the neurovasculture, Stryker Detachable Coils are MR Conditional. A patient with Stryker Detachable Coils can be safely scanned immediately after placement of the coils, under the following conditions: Static magnetic field of 1.5 or.0 Tesla Spatial gradient field up to 500 Gauss/cm (5 Tesla/m) Normal operational mode for gradients and SAR (maximum whole body averaged specific absorption rate (SAR) of lower than.0 W/kg and maximum head SAR of lower than. W/kg) for a total active MR scan time (with RF exposure) of minutes or less per scan sequence. In an analysis based on the temperature rises in non-clinical testing of spherical aneurysm models, the Detachable Coils were determined to produce an in-vivo temperature rise of oc or less for minutes of MR scanning in normal mode operation in 1.5 T and T MR systems. The Detachable Coils should not migrate in this MRI environment. Temperature testing was not conducted in arteriovenous malformations or fistulae models. MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imagining parameters for the presence of this implant. GDC Detachable Coils, GDC 0o Detachable Coils, GDC 1-Fibered VortX Detachable Coils, Matrix Detachable Coils, and Target Detachable Coils Magnetic Resonance Imagining (MRI) Compatibility (Peripheral Use) Non-clinical testing and analysis have demonstrated that when used in peripheral vasculature Stryker Detachable Coils are MR Conditional. A patient can be safely scanned immediately after placement of the coils, under the following conditions: Static magnetic field of 1.5 and.0 Tesla Spatial gradient field up to 500 Gauss/cm (5 Tesla/m) Normal operational mode for gradients and SAR (maximum whole body averaged specific absorption rate (SAR) of lower than.0 W/kg and maximum head SAR of lower than. W/kg) for a total of active MR scan time (with RF exposure) of minutes or less per scan sequence. In an analysis based on the temperature rises in non-clinical testing of a bundle of 0 test coils with a length of 9mm and the calculated SAR in the patient during MR scan, the test coils were determined to produce an in-vivo temperature rise of 7.oC or lower for minutes of MR scanning in normal operational mode in 1.5 T and T MR systems. The Detachable Coils should not migrate in this MRI environment. The SAR limit of W/kg applies only for coil placement in the torso. A reduction of SAR limits may be appropriate for coil placement in the legs or arms. MR image quality may be compromised if the area if interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.

2 Neuroform Microdelivery Stent System, Neuroform EZ Stent System Magnetic Resonance Imagining (MRI) Compatibility Non-clinical testing and analysis have demonstrated that Neuroform Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neurovascular coil mass. A patient with Neuroform Stent can be safely scanned immediately after placement of this implant, under the following conditions: Static magnetic field of 1.5 and.0 Tesla Spatial gradient field up to 500 Gauss/cm (5 Tesla/m) Normal operational mode for gradients and SAR (maximum whole body averaged specific absorption rate (SAR) of lower than.0 W/kg and maximum head SAR of lower than. W/kg) for a total active MR scan time (with RF exposure of minutes or less per scan sequence. In an analysis based on the temperature rises in non-clinical testing of stents and the calculated SAR in the patient during an MR scan, Neuroform Stents were determined to product an in-vivo temperature rise of.0oc of lower for minutes of MR scanning in normal operational mode of 1.5 T and T MR systems. The Neuroform Stent should not migrate in this MRI environment. MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant. //1

3 Target 0 Nano Coils Catalog Number Secondary Diameter (mm) Length in Introducer (cm) M005 1 M0050 M005 M M0050 M0050 M0050 M M00500 M00500 M Target Helical Nano Coils Catalog Number Secondary Diameter (mm) Length in Introducer (cm) M005 1 M005 1 M0050 M005 1 M M0050 M0050 M0055 M00550 M00550 M00550 M M M M M M005500

4 Target XL 0 Standard M000 M M M M000 0 M M M M M M M Target XL 0 Soft M00 M M000 0 M M M M M M M Target XL Helical M00 5 M001 M M M M M M M M M00 50 M00 50 M00 50

5 Target 0 Standard Coils M00500 M00500 M00500 M0050 M0050 M M00550 M0050 M0050 M M00570 M M M0050 M M M M M M M M M Target 0 Soft Coils M00570 M M M00570 M M M00570 M00570 M00570 M M M00570 M00570 M00570 M M M M M00570 M M M M M M M M

6 Target 0 Ultra Coils M0050 M0050 M0050 M M00500 M00500 M00500 M0050 M0050 M0050 M0050 M0050 M M00550 Target D Detachable Coils M0000 M0000 M M000 M M M000 0

MRI Conditional Devices and Patient Safety. Outline. MRI Labeling: Objects 8/3/13 1. David W. Jordan, Ph.D. Senior Medical Physicist

MRI Conditional Devices and Patient Safety David W. Jordan, Ph.D. Senior Medical Physicist 8/3/13 1 Outline MRI Conditional Overview Spatial Gradient Hazards RF SAR Hazards Device Registries MRI Labeling: