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Iliac artery stent graft BeGraft +
peripheralrenal arterycobalt-chromium

iliac artery stent graft
iliac artery stent graft
iliac artery stent graft
iliac artery stent graft
iliac artery stent graft
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Characteristics

Type
iliac artery, peripheral, renal artery
Material
cobalt-chromium, ePTFE
Diameter

5 mm, 7 mm, 8 mm, 9 mm, 10 mm
(0.197 in, 0.276 in, 0.315 in, 0.354 in, 0.394 in)

Length

27 mm, 28 mm, 38 mm, 57 mm, 58 mm
(1.063 in, 1.102 in, 1.496 in, 2.244 in, 2.283 in)

Description

The BeGraft Peripheral PLUS Stent Graft System is indicated for intraluminal chronic placement in iliac and renal arteries for: Restoring and improving the patency Treating aneurysms, acute perforations, acute ruptures and fistulas MRI statements Non-clinical testing has demonstrated that the “BeGraft Peripheral Plus Stent Graft” is MR Conditional. A patient with this device can be safely scanned immediately after implantation in an MR system meeting the following conditions: static magnetic field of 1.5 Tesla and 3 Tesla, with maximum spatial field gradient of 5,700 G/cm (57 T/m) maximum force product of 102,000,000 G²/cm (102 T²/m) theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR) of 2 W/kg (normal operating mode) Under the scan conditions defined above, the “BeGraft Peripheral Plus Stent Graft” is expected to produce a maximum temperature rise of less than 2.9°C (2 W/kg, 1.5 Tesla) RF-related temperature increase with a background temperature increase of ≈ 1.5°C (2 W/kg, 1.5 Tesla) 2.1°C (2 W/kg, 3 Tesla) RF-related temperature increase with a background temperature increase of ≈ 0.9°C (2 W/kg, 3 Tesla) after 15 minutes of continuous scanning. The effect of heating in the MRI environment for overlapping stent grafts or stent grafts with fractured struts is not known. In non-clinical testing, the image artifact caused by the device extends approximately 14.6 mm from the “BeGraft Peripheral Plus Stent Graft” when imaged with a gradient echo pulse sequence and a 3 Tesla MR system.

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