Cera

Primary DI

08720214006248

Basic UDI-DI Code

B-08720214006248

Reference

LE-VSD-Ecc-06

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

LifeTech Scientific (Europe) B.V.

The CeraTM VSD Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of a ventricular septal defect in patients. The occluder is a self-expandable, double discs device made from a nitinol wire mesh. The two discs are linked together by a short cylindrical waist matching with the size of the VSD., The discs and waist are filled with PTFE membranes securely sewn to the device by nylon threads to increase closing ability of the occluder and reduce the residual shunts. The metallic skeleton is plated with biological ceramic coating to improve the biocompatibility. The ceramic coating reduces the electrochemical erosion and the Nickel ion concentration in blood and endocardium. The high biocompatibility of the biological ceramic coating induces better and faster endothelialization of the device. There are muscular VSD and membranous VSD (Symmetric; Asymmetric; Eccentric) occluders, which are selected in accordance with the anatomical conditions and/or based on overall medical condition by trained physicians/doctors.

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