Vascutek Thoraflex Hybrid Instrucciones De Uso página 5

MAGNETIC RESONANCE IMAGING SAFETY
The Thoraflex Hybrid™ Device was determined to be MR-conditional.
Non-clinical testing demonstrated that grafts with radiopaque markers were determined to be MR conditional. A
patient with this device can be scanned safely, immediately after placement under the following conditions:
Static Magnetic Field
-Static magnetic field of 3-Tesla or less
-Maximum spatial gradient magnetic field of 720-Gauss/cm or less
MRI-Related Heating
In non-clinical testing, the grafts with radiopaque markers produced the following temperature rises during MRI
performed for 15 minutes of scanning (i.e., per pulse sequence) in 1.5-Tesla/64-MHz (Magnetom, Siemens Medical
Solutions, Malverm PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded, horizontal field
scanner) and 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee,
WI) MR systems:
MR system reported, whole body averaged SAR
Calorimetry measured values, whole body averaged SAR
Highest temperature change
These temperature changes will not pose a hazard to a human subject under the conditions indicated above.
Artefact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the
position of the graft with radiopaque markers. Therefore, optimization of MR imaging parameters to compensate
for the presence of this device may be necessary. The maximum artefact size (i.e. as seen on the gradient echo
pulse sequence) extends approximately 10-mm relative to the size and shape of this implant.
Pulse Sequence
Signal Void Size
Plane Orientation
This information is based on the latest information from the Food and Drug Administration and the American Society for Testing and
Materials (ASTM) International, Designation: F2503-08. Standard Practice for Marketing Medical Devices and Other Items for Safety
in the Magnetic Resonance Environment.
Origin of Gelatin
Vascutek Ltd uses gelatin manufactured from animals native to, and exclusively raised in Australia. Australia is
one of only a few countries recognised as free from TSE infected animals, including BSE and scrapie. The EU
Scientific Steering Committee has conducted Geographical BSE Risk Assessment (GBR) and concluded that
Australia has the most favourable category 1 rating in relation to BSE risk.
Indications
The Vascutek Thoraflex Hybrid™ device is intended for use in the "Frozen Elephant Trunk" procedure to replace
the aortic arch and repair aneurysm and/or dissection of the descending aorta in a single surgical procedure.
Contraindications
• These prostheses should not be implanted in patients who exhibit sensitivity to polyester, nitinol, or materials
of bovine origin
Cautions
1. The vascular graft is based on a woven structure and therefore should be cut with a cautery to minimize fraying.
A pre-sterilized cautery is included with each device. Note: Immersion of the device in saline immediately prior to
use, will prevent focal burning, which may result during cauterization. The device should be immersed in saline for
no longer than 5 minutes and shall not be allowed to dry out after soaking.
2. The device, in particular the stent graft, must be pre-soaked as advised. Pre-soaking the stent graft will greatly
reduce the force during deployment.
3. DO NOT PRECLOT. These prostheses contain a gelatin sealant and must not be preclotted.
4. DO NOT USE BEYOND THE INDICATED EXPIRATION DATE. The gelatin impregnation may not meet the
design specification after the expiration date because of hydrolytic action.
5. DO NOT RE-STERILISE. FOR SINGLE USE ONLY. Do not re-sterilise. Do not reuse, reprocess or re-sterilise.
Reuse, reprocessing or re-sterilisation may compromise the structural integrity of the device and/or lead to
device failure which, in turn, may result in deterioration of health or death of patients. Reuse, reprocessing or re-
T1-SE
15, 818-mm 1, 424-mm
2
Parallel Perpendicular
1.5-Tesla
2.9-W/kg
2.1-W/kg
+1.7 °C
T1-SE GRE
19, 077-mm
2
Parallel
3-Tesla
2.9-W/kg
2.7-W/kg
+2.0 °C
GRE
2, 012-mm
2 2
Perpendicular
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