Cera

Primary DI

08720214005760

Basic UDI-DI Code

B-08720214005760

Reference

LE-PDA-1214

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

LifeTech Scientific (Europe) B.V.

The Cera PDA Occluder is a percutaneous transcatheter occluder for the non-surgical closure of patent ductus arteriosus defects. The device consists of a knitted nitinol wire mesh, which has been heat set to expand to a T-shape. The disc on the aorta side is designed to hold the plug at the orifice of the ductus arteriosus, while the waist expands to fill and occlude it. An PTFE membrane is sewn inside the disc with nylon thread on the aorta side, and two PTFE membranes are sewn inside the waist to help blocking the abnormal blood flow from the aorta into the pulmonary artery. All metallic structures are plated with a titanium nitride (TiN) bioceramic coating (applied by vacuum plasma deposition technology), to effectively reduce the release of nickel ions into blood and surrounding tissues in order to mitigate thrombogenicity of the device and to speed up endothelial cell growth on the surface of device.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).