Zenith Low Profile AAA Endovascular Graft Main Body Extension - Graft, vascular, synthetic

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Предлага се от:

William A Cook Australia Pty Ltd

Клас:

Class III

Произведено от:

William Cook Europe ApS Sandet 6, Bjaeverskov, 4632 Denmark

Терапевтична област:

35281 - Graft, vascular, synthetic

Терапевтични показания:

The Zenith Low Profile AAA Endovascular Graft Main Body Extension can be used to provide additional length to the proximal portion of the endovascular graft. The Main Body Extension utilises a 16Fr or 17 Fr H&L-B One-Shot Introduction system which contains a single trigger-wire relese mechanism and deploys the Main Body Extension by sheath retraction and removal of the distal trigger wire. The Zenith Low Profile AAA Endovascular Graft ancillary component, Main Body Extension, (ZLBE), is indicated for the treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including: ? Iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 French (6.0mm OD) or 17 French (6.5mm OD) vascular introducer sheath; ? Non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: o With a length of at least 15mm o With a diameter measured outer wall to outer wall of no greater than 32mm and no less than 18mm o With an angle less than 60 degrees relative to the long axis of the aneurysm, and o With an angle less than 45 degrees relative to the axis of the suprarenal aorta. ? Iliac artery distal fixation site greater than 10mm in length and 8 to 20mm in diameter (measured outer wall to outer wall).

Статус Оторизация:

A

Дата Оторизация:

2014-08-20