An artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace
| Company | Devices | Share |
|---|---|---|
| St. Jude Medical, Inc. | 22 | 41% |
| Medtronic, Inc. | 15 | 28% |
| Corcym Srl | 12 | 22% |
| On-X Life Technologies, Inc. | 5 | 9% |
Company = labeler of record on GUDID. 4 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 |
|---|---|---|
| LWQ | HEART-VALVE, MECHANICAL | 76 |
| LWQ | Heart-Valve, Mechanical | 5 |
Use these as the dimensions to specify in a tender line.
54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft", from 4 companies. The largest labeler is St. Jude Medical, Inc. with 41% of records.
LWQ (HEART-VALVE, MECHANICAL), LWQ (Heart-Valve, Mechanical)
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.