Cook Zenith Helical Iliac Sidebranch Endovascular Graft

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

COOK SOUTH EAST ASIA PTE LTD

Class:

Class D medical device

Manufactured by:

William A. Cook Australia Pty Ltd

Therapeutic area:

Cardiovascular

Therapeutic indications:

The Zenith Helical Iliac Sidebranch Endovascular Graft with the H&L-B One-Shot Introduction System is indicated for the endovascular treatment of patients with an aortoiliac or iliac aneurysm, an insufficient distal sealing site within the common iliac artery, and having morphology suitable for endovascular repair, including: • Adequate iliac/femoral access compatible with a 20 French (7.8 mm O.D.) introduction system, • Non-aneurysmal external iliac artery fixation segment distal to the aneurysm: - With a length of at least 20 mm, - With a diameter measured outer wall to outer wall of no greater than 11 mm and no less than 8 mm. • Non-aneurysmal internal iliac artery segment distal to the aneurysm: - With a length of at least 10 mm, - With a diameter acceptable for proper sealing.

Product summary:

Device System Info:[Sterile Medical Device], EO sterilisation; Models: Zenith Helical Iliac Sidebranch Endovascular Graft - ZHIS-8-L, Zenith Helical Iliac Sidebranch Endovascular Graft* - ZHIS-8-R, Zenith Crimped Leg Extension Endovascular Graft - ZCLE-12-76, Zenith Crimped Leg Extension Endovascular Graft* - ZCLE-12-59

Authorization date:

2012-03-20