Zenith t-Branch Thoracoabdominal Endovascular Graft - Graft, vascular, synthetic

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Sẵn có từ:

William A Cook Australia Pty Ltd

Lớp học:

Class III

Sản xuất bởi:

William Cook Europe ApS Sandet 6, Bjaeverskov, 4632 Denmark

Khu trị liệu:

35281 - Graft, vascular, synthetic

Chỉ dẫn điều trị:

The Zenith t-Branch is a tubular endovascular graft with four branches and with a covered stent at the proximal end that contains barbs for additional fixation of the device. The graft is designed to be connected with the coeliac, superior mesenteric and two renal arteries. The Zenith t-Branch is shipped loaded onto the H&L-B One-Shot Introduction System. It has a sequential deployment method with built-in features to provide continuous control of the graft throughout the deployment process. The Zenith t-Branch Thoracoabdominal Endovascular Graft is indicated for the endovascular treatment of high-risk patients with thoracoabdominal aneurysms who are not amenable to open surgical repair. The patients must have morphology suitable for endovascular repair, including: a) Adequate iliac/femoral access compatible with a 22 Fr / 8.5 mm OD introduction system, b) Non-aneurysmal thoracic aorta fixation segment proximal to the aneurysm: - With an angle less than 90 degrees relative to the long axis of the aneurysm - With a length of at least 25 mm, (50 mm of wall contact is preferred) - With a diameter measured outer wall to outer wall of no greater than 30 mm and no less than 24 mm - Alternatively, the Zenith t-Branch graft may be attached to a pre-existing endovascular graft such as the Zenith TX2 TAA Endovascular Graft. c) Visceral vessel anatomy compatible with Zenith t-branch, specifically: - Four indispensible arteries from the abdominal viscera - All target arteries to be accessible from an antegrade approach - Coeliac and superior mesenteric artery (SMA) to be 6 mm to 10 mm in diameter - Renal arteries to be 4 mm to 8 mm in diameter - The distance between each cuff and the corresponding arterial orifice is less than 50 mm - The line between the cuff and the arterial orifice as projected onto the vessel wall deviates by no more than 45 degrees from the long axis of the aorta.

Tình trạng ủy quyền:

A

Ngày ủy quyền:

2014-09-17