Safe by Design
- The EmeryGlide is constructed from a high strength core composite of glass fibers and polymers, protected by a double winding of aramid fibers embedded in polymer.
- There is a full body (tip to end) PTFE sleeve that minimizes intravascular friction and protects the tip and shaft from breakage.
- The distal tip of the EmeryGlide is marked with 3 discrete markers containing different nanoparticles that enable visibility under MRI as well as fluoroscopy.
- The passive markers are positioned 0cm, 2cm and 4cm from the straight or angled tip.
MR Conditional Statement
Non-clinical testing has demonstrated that the EmeryGlide MR Guidewire is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5 or 3.0 T
- Maximum spatial field gradient of 3600 Gauss/cm (36.0 T/m) for 1.5 T systems
- Maximum spatial field gradient of 1800 Gauss/cm (18.0 T/m) for 3.0 T systems
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Operating Mode at 1.5 T)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Operating Mode at 3.0 T)
Under the scan conditions defined above, EmeryGlide MR Guidewire is expected to produce a maximum temperature rise of less than 0.6 °C after 15 minutes continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 8mm from the EmeryGlide MR Guidewire when imaged with a gradient echo pulse sequence and a 3 T MRI system.
Indications for Use
The EmeryGlide MR Guidewire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.