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 TrelliX Embolic Coil System, All Versions

Shape Memory Medical, Inc., www.shapemem.com

MRI Safety Information

Non-clinical testing and MRI simulations were performed to evaluate the entire family (i.e., available diameters and lengths) of the TrelliX Embolic Coil System. Non-clinical testing demonstrated that the entire family of these embolization coils is MR Conditional. A patient with an implant from this family can be scanned safely in an MR system under the following conditions:

• Static magnetic field of 1.5-Tesla or 3-Tesla, only

• Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)

• Maximum MR system reported, whole body averaged specific absorption rate (SAR) ofm2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode

 

Strength: 1.5, 3
Conditional 8 Coils, Filters, Stents, and Grafts

2D Helical, 35 Fibered Platinum Coil.
Boston Scientific, www.bostonscientific.com

Strength: 1.5, 3
Conditional 5 Coils, Filters, Stents, and Grafts

3/4" Socket Wrench
3/4" *41-mm
Newmatic Medical, www.newmaticmedical.com

Strength: 3
Conditional 7 Miscellaneous Implants and Devices

30 Caliber, 762 x 39, Copper Jacketed Round, Armor Piercing, Norinco

Strength: 1.5
Unsafe 1 Miscellaneous Implants and Devices

357 Magnum Revolver
Model 66-3
Misc.
Smith and Wesson
Springfield, MA

Strength: 1.5
Unsafe 1 Miscellaneous Implants and Devices

3D Interstitial Ring Applicator 90º with Plastic Needles
Varian Medical Systems, www.varian.com

Strength: 1.5, 3
Conditional 8 Miscellaneous Implants and Devices

3D Interstitial Ring Applicator with Plastic Needles
Varian Medical Systems, www.varian.com

Strength: 1.5, 3
Conditional 5 Miscellaneous Implants and Devices

3D ProFuse Bioscaffold Safe
Alphatec Spine Inc., www.alphatecspine.com

Strength: 1.5, 3
Safe Orthopedic Implants, Materials, and Devices

3M Kind Removal Silicone Tape
3M, www.3m.com

Strength: 1.5,3
Safe Miscellaneous Implants and Devices

3M PICC/CVC Securement Device + Tegaderm I.V. Advanced Securement Dressing
3M, www.3m.com

Strength: 1.5,3
Safe Miscellaneous Implants and Devices

3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
3M, www.3m.com

Strength: 1.5, 3
Safe Miscellaneous Implants and Devices

3M Tegaderm Silicone Foam Border Dressing
3M, www.3m.com

Strength: 1.5,3
Safe Miscellaneous Implants and Devices

4-Leg Base IV Stand, Stainless Steel
Pryor Products
Oceanside, CA

Strength: 3
Conditional 7 Miscellaneous Implants and Devices

4D Dome Semi-resorbable Parietal Reinforcement Implant
Cousin Biotech, www.cousin-biotech.com

Strength: 1.5, 3
Safe Miscellaneous Implants and Devices

4D Mesh Semi-resorbable Parietal Reinforcement Implant
Cousin Biotech, www.cousin-biotech.com

Strength: 1.5, 3
Safe Miscellaneous Implants and Devices
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