A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or t
| Company | Devices | Share |
|---|---|---|
| Medtronic, Inc. | 111 | 42% |
| Edwards Lifesciences Llc | 81 | 31% |
| St. Jude Medical, Inc. | 56 | 21% |
| Corcym Canada Corp | 9 | 3% |
| Corcym Srl | 8 | 3% |
Company = labeler of record on GUDID. 5 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 |
|---|---|---|
| LWR | heart-valve, non-allograft tissue | 262 |
| DYE | replacement Heart-valve | 100 |
| LWR | Heart-Valve, Non-Allograft Tissue | 14 |
| DYE | Replacement Heart-Valve | 11 |
Use these as the dimensions to specify in a tender line.
265 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Aortic open-surgery heart valve bioprosthesis", from 5 companies. The largest labeler is Medtronic, Inc. with 42% of records.
LWR (heart-valve, non-allograft tissue), DYE (replacement Heart-valve), LWR (Heart-Valve, Non-Allograft Tissue), DYE (Replacement Heart-Valve)
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.