TLA GUT (UC)

Primary DI

D-70-SS-bTECKAA

Basic UDI-DI Code

B-70-SS-bTECKAA

Reference

00170-SS-bTECK

Device Types

Single use

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

TLA Targeted Immunotherapies AB

A hemoperfusion device intended for extracorporeal filtration of blood cells for the treatment of patients with inflammatory bowel disorders (IBD), specifically ulcerative colitis (UC). The TLA GUT device is a column consisting of a plastic container which in both ends carry luer plug connections that allow for connection with an apheresis machine intended for hemoperfusion, through a tubing set. The contents of the TLA GUT column are a matrix bead slurry to which a biologically active peptide has been coupled working as the ligand to the chemokine receptor CCR9, which is highly expressed on lymphocytes in patients with IBD. When the blood is passed through the TLA GUT column, blood cells of a specific disease-causing type are trapped by the chemokine-chemokine receptor interaction. The full blood volume, including the remaining un-bound blood cells, is subsequently returned to the patient through the other arm.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).