A non-bioabsorbable, tubular, fenestrated (with side holes) device intended for endovascular implantation, in a modular configuration, to repair lesions of the aortic arch and descending thoracic aorta. It is in the form of a metallic, outer mesh with an inner
| Company | Devices | Share |
|---|---|---|
| Endospan Ltd | 65 | 68% |
| W. L. Gore & Associates, Inc. | 31 | 32% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| SDZ | Endovascular System For Treatment Of Ascending Aorta And Aor | 65 |
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 26 |
| MIH | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 5 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
96 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Aortic arch endovascular stent-graft", from 2 companies. The largest labeler is Endospan Ltd with 68% of records.
SDZ (Endovascular System For Treatment Of Ascending Aorta And Aor), MIH (System, Endovascular Graft, Aortic Aneurysm Treatment), MIH (SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.