Consulting Wallah › Device Explorer › Cardiovascular › Cardiovascular patch, animal-derived
Device Explorer · FDA GUDID · GMDN 35273

Cardiovascular patch, animal-derived

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy,

US‑registered devices281in commercial distribution
Companies15labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Intervascular Sas6623%
Admedus Regen Pty Ltd4215%
Lemaitre Vascular, Inc.3914%
Synovis Life Technologies, Inc.3011%
Vascutek Ltd269%
Tisgenx, Inc.249%
Artivion, Inc.176%
Elutia Inc.93%

Top labelers

CompanyDevicesShare
Intervascular Sas6623%
Admedus Regen Pty Ltd4215%
Lemaitre Vascular, Inc.3914%
Synovis Life Technologies, Inc.3011%
Vascutek Ltd269%
Tisgenx, Inc.249%
Artivion, Inc.176%
Elutia Inc.93%
Helios Cardio Inc.93%
Boston Scientific Corporation72%
St. Jude Medical, Inc.41%
Edwards Lifesciences Llc41%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SJM™ThinwallGelsoft™ Cardiovascular PatchGelseal™ Cardiovascular PatchPhotoFix Decellularized Bovine PericardiumVasCure for Vascular RepairTyke, Patch, Pledget and IntracardiacVasCure for Carotid RepairProxiCor for Cardiac Tissue RepairProxiCor for Pericardial ClosureInvengenxCardiaMendCorMatrix(R) Cor(TM) PATCH Epicardial Patch, FivCorMatrix(R) Cor(TM) PATCH Epicardial Patch, FivN/ACardioCel Neo Bioscaffold Patch 5 cm X 8 cm

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

FDA product codes

CodeNameDevices
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene75
FTMMesh, Surgical61
DXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE55
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter49
PSQIntracardiac Patch Or Pledget, Biologically Derived46
FTMMesh, surgical26

GMDN & GCC registration

  • GMDN code 35273 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · 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

Length (Centimeter) · 114Width (Centimeter) · 100Width (Millimeter) · 51Length (Millimeter) · 49Height (Centimeter) · 36Height (Millimeter) · 9

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

How many cardiovascular patch, animal-derived products are registered in the US?

281 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiovascular patch, animal-derived", from 15 companies. The largest labeler is Intervascular Sas with 23% of records.

Which FDA product codes apply?

DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), FTM (Mesh, Surgical), DXZ (PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE), DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)

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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