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 mitral heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or t
| Company | Devices | Share |
|---|---|---|
| Edwards Lifesciences Llc | 36 | 41% |
| Medtronic, Inc. | 31 | 36% |
| St. Jude Medical, Inc. | 20 | 23% |
Company = labeler of record on GUDID. 3 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 |
|---|---|---|
| DYE | replacement Heart-valve | 57 |
| LWR | heart-valve, non-allograft tissue | 47 |
| LWR | Heart-Valve, Non-Allograft Tissue | 5 |
Use these as the dimensions to specify in a tender line.
87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mitral open-surgery heart valve bioprosthesis", from 3 companies. The largest labeler is Edwards Lifesciences Llc with 41% of records.
DYE (replacement Heart-valve), LWR (heart-valve, non-allograft tissue), LWR (Heart-Valve, Non-Allograft Tissue)
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.