Urology and Pelvic Health 10700 Bren Road West Minnetonka, MN 55343 952.930.6000 www.bostonscientific.com
August 2015
MRI Information Several Magnetic Resonance Imaging (MRI) studies have concluded that the AMS products listed below w ill not produce additional risks to patients in association w ith MRI procedures under the conditions used for testing. In these investigations, AMS products underw ent evaluations for magnetic field interactions at 1.5 and/or 3.0 Tesla. No unsafe magnetic field interactions w ere identified by this research. 1 MRI Safe The follow ing AMS product does not contain metallic components and therefore is considered MRI Safe. •
AdVance™ Male Sling System
MRI Conditional (“MR Conditional”) Some AMS products are MRI Conditional up to 3.0 Tesla. These products include: • AMS 800 ™ Urinary Control System • Inflatable Penile Prostheses: AMS 700 ™ CX , CXM, CXR, Ultrex ™, Ultrex Plus, AMS 700 LGX ™ • AMS Ambicor™ Inflatable Penile Prostheses • Spectra™ Penile Prostheses MR parameters for these products are provided in the individual device’ s instructions for use as w ell as on pages 3-5 of this document. Additional MRI testing w as conducted on some AMS devices at 1.5 and 3.0 Tesla to evaluate the impact of MR imaging on the devices that contain metallic components. Testing conducted at 1.5 Tesla concluded that torque, deflection angle, and heating/temperature change results for the follow ing products w ere found acceptable: • AMS Artificial Urinary Sphincters 791 ™ and 792 ™ • InVance™ Male Incontinence Sling System • Malleables: Dynaflex ™ / Hydroflex™ • Malleables: AMS 600 ™ / 600M™/ 650 ™ / Dura II™; and Spectra™ • UroLume™ Endoprosthetic Stent • AMS Mainstay ™ Urologic Soft Tissue Anchor
1. Data on File
Urology and Pelvic Health 10700 Bren Road West Minnetonka, MN 55343 952.930.6000 www.bostonscientific.com
Testing conducted at 3.0 Tesla concluded that torque and deflection angle results for the follow ing products w ere found acceptable: • AMS Artificial Urinary Sphincters 791 ™ and 792 ™ • InVance™ Male Incontinence Sling System • Malleables: Dynaflex ™ / Hydroflex ™ • Malleables: AMS 600 ™ / 600M ™ / 650 ™ / Dura II™ • UroLume™ Endoprosthetic Stent • AMS Mainstay™Urologic Soft Tissue Anchor
AMS Company Contact: Elizabeth Rae, AMS Senior Patient Liaison, at 800-328-3881 extension 6261, or 952-930-6261, or Email at [email protected], Monday-Friday until 4:00pm Central Time.
Urology and Pelvic Health 10700 Bren Road West Minnetonka, MN 55343 952.930.6000 www.bostonscientific.com
AMS 700 ™ and AMS Ambicor™ Penile Prostheses Additional data Magnetic Resonance Imaging (MRI) Important Safety Information Non-clinical testing has demonstrated the penile prostheses AMS 700 ™ / AMS Ambicor™ product line is MR Conditional. The device can be scanned safely under the follow ing conditions: Static Magnetic Field 1 . 5 Tesla a 3.0 Teslab Spatial Gradient Field 450 Gauss/cm or less 720 Gauss/cm or less Maximum w hole body 1.5 W/kg for 15 minutes 2.9 W/kg for 15 minutes of averaged Specific of scanning as assessed scanning as assessed by Absorption Rate (SAR) by calorimetry calorimetry (a) 1.5T - 64 MHz MR System (General Electric Healthcare, Milw aukee, WI) (b) 3.0T MR Excite, General Electric Healthcare, softw are version 14X.M5
MRI-Related Heating Non-clinical testing has demonstrated the penile prostheses AMS 700 ™ / AMS Ambicor™ product line produced the temperature rises during MRI performed for 15 minutes of scanning in the respective MR systems w hich w ould not pose a hazard to the human subject. 3.0 Teslab Static Magnetic Field 1 . 5 Tesla a Highest Temperature Change
≤ + 0.4° C
≤ + 1.9° C
(a) 1.5T - 64 MHz MR System (General Electric Healthcare, Milw aukee, WI) (b) 3.0T MR Excite, General Electric Healthcare, softw are version 14X.M5
Artifact Information Non-clinical testing has demonstrated that the penile prostheses AMS 700 ™ / AMS Ambicor™ product line may compromise the MR image quality if the area of interest is relatively close to the position of the implant. The maximum image artifact produced by a MR gradient echo pulse sequence w as a “ moderate” localized signal void in size and shape of the implant. Optimization of MR imaging parameters to compensate for the presence of the device may be necessary. Pulse Sequence
T1 -SE
T1-SE
GRE
GRE
Signal Void Size
6,244 mm2
1,589 mm2
10,295 mrn2
2,779 mm 2
Plane Orientation
Parallel
Perpendicular
Parallel
Perpendicular
Urology and Pelvic Health 10700 Bren Road West Minnetonka, MN 55343 952.930.6000 www.bostonscientific.com
AMS 800 ™ Urinary Control System Additional data Magnetic Resonance Imaging (MRI) Important Safety Information Non-clinical testing has demonstrated the AMS 800 ™ Urinary Control System product line is MR Conditional. The device can be scanned safely under the follow ing conditions: Static Magnetic Field 1 . 5 Tesla a 3.0 Teslab Spatial Gradient Field 450 Gauss/cm or less 720 Gauss/cm or less Maximum w hole body averaged Specific Absorption Rate (SAR)
1.5 W/kg for 15 minutes of scanning as assessed by calorimetry
2.9 W/kg for 15 minutes of scanning as assessed by calorimetry
(a) 1.5T - 64 MHz MR System (General Electric Healthcare, Milw aukee, WI) (b) 3.0T MR Excite, General Electric Healthcare, softw are version 14X.M5 MRI-Related Heating Non-clinical testing has demonstrated the AMS 800 ™ Urinary Control System product line produced the temperature rises during MRI performed for 15 minutes of scanning in the respective MR systems w hich w ould not pose a hazard to the human subject. Static Magnetic Field 1 . 5 Tesla a 3.0 Teslab Highest Temperature Change
≤ + 0.4° C
≤ + 2.0 ° C
(a) 1.5T - 64 MHz MR System (General Electric Healthcare, Milw aukee, WI) (b) 3.0T MR Excite, General Electric Healthcare, softw are version 14X.M5
Artifact Information Non-clinical testing has demonst rat ed that the AMS 800 ™ Urinary Control System product line may compromise the MR image quality if the area of interest is relatively close to the position of the implant. The maximum image artifact produced by a MR gradient echo pulse sequence w as a “ moderate” localized signal void in size and shape of the implant. Optimization of MR imaging parameters to compensate for the presence of the device may be necessary. Pulse Sequence T1 -SE T1-SE GRE GRE Signal Void Size
5,800 mm2
1,956 mm2
6,096 mrn2
2,650 mm 2
Plane Orientation
Parallel
Perpendicular
Parallel
Perpendicular
Urology and Pelvic Health 10700 Bren Road West Minnetonka, MN 55343 952.930.6000 www.bostonscientific.com
Spectra™ Concealable Penile Prosthesis Additional data Magnetic Resonance Imaging (MRI) Important Safety Information Non-clinical testing has demonstrated the Spectra™ Concealable Penile Prosthesis product line is MR Conditional. The device can be scanned safely under the follow ing conditions: St at ic Magnetic Field ≤ 3.0 Teslaa Spatial Gradient Field
720 Gauss/cm or less
Maximum w hole body averaged Specific Absorption Rate (SAR)
2.9 W/kg for 15 minutes of scanning as assessed by calorimetry
(a) 3.0T 128MHz, General Electric Healthcare, Excite softw are version G3.0-052B MRI-Related Heating Non-clinical testing has demonstrated the Spectra™ Concealable Penile Prosthesis ABS product line produced the temperature rises during MRI performed for 15 minutes of scanning in the respective MR systems w hich w ould not pose a hazard to the human subject. Static Magnetic Field ≤ 3.0 Teslaa ≤ + 1.6° C
Highest Temperature Change
(a) 3.0T 128MHz, General Electric Healthcare, Excite softw are version G3.0-052B Artifact Information Non-clinical testing has demonstrated that the Spectra™ Concealable Penile Prosthesis product line may compromise the MR image quality if the area of interest is relatively close to the position of the implant. The maximum image artifact produced by a MR gradient echo pulse sequence w as a “ moderate” localized signal void in size and shape of the implant. Optimization of MR imaging parameters to compensate for the presence of the device may be necessary. Pulse Sequence T1 -SE T1-SE GRE GRE Signal Void Size
7,193 mm 2
1,553 mm2
1,160 mrn2
7,030 mm 2
Plane Orientation
Parallel
Perpendicular
Parallel
Perpendicular
This letter contains important safety information on the use of magnetic resonance imaging w ith AMS’ products. For additional product information on indications for use, contraindications, w arnings, precautions, and adverse events, please refer to the product’ s instructions for use.
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