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Device Explorer · FDA GUDID · GMDN 60245

Aortic transcatheter heart valve bioprosthesis, stent-like framework

An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarter

US‑registered devices84in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription83%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medtronic Corevalve Llc4351%
Edwards Lifesciences Llc1619%
St. Jude Medical, Inc.1417%
Jenavalve Technology, Inc.67%
Medtronic, Inc.56%

Top labelers

CompanyDevicesShare
Medtronic Corevalve Llc4351%
Edwards Lifesciences Llc1619%
St. Jude Medical, Inc.1417%
Jenavalve Technology, Inc.67%
Medtronic, Inc.56%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Navitor™Navitor Titan™Portico™Trilogy Transcatheter Heart ValveEvolut™ FXEvolut™ FX+Evolut™ PRO+CoreValve™ Evolut™ PROCoreValve™ Evolut™ RSAPIEN 3 Ultra RESILIASAPIEN 3 Ultra SystemEDWARDS CERTITUDE DELIVERY SYSTEM26MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEM23MM X 3CM X 105CM NOVAFLEX+ DELIVERY SYSTEMEDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THVEDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV)

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NPTAortic valve, prosthesis, percutaneously delivered104
NPTAortic Valve, Prosthesis, Percutaneously Delivered13
NPUProsthesis, Mitral Valve, Percutaneously Delivered11
NPVPulmonary Valve Prosthesis Percutaneously Delivered2

GMDN & GCC registration

  • GMDN code 60245 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 83% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 26Length (Centimeter) · 10

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many aortic transcatheter heart valve bioprosthesis, stent-like framework products are registered in the US?

84 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Aortic transcatheter heart valve bioprosthesis, stent-like framework", from 5 companies. The largest labeler is Medtronic Corevalve Llc with 51% of records.

Which FDA product codes apply?

NPT (Aortic valve, prosthesis, percutaneously delivered), NPT (Aortic Valve, Prosthesis, Percutaneously Delivered), NPU (Prosthesis, Mitral Valve, Percutaneously Delivered), NPV (Pulmonary Valve Prosthesis Percutaneously Delivered)

Is this the same as UAE/GCC registration?

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.

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