LAmbre

Primary DI

06938370124856

Basic UDI-DI Code

B-06938370124856

Reference

LT-LAA-2228

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Lifetech Scientific (Shenzhen) Co., Ltd.

The Left Atrial Appendage Closure System is a transcatheter, self-expanding device intended for cardiac structures not involving the septal wall, which require closure or occlusion. The System consists of a Left Atrial Appendage Occluder and a Delivery System. The Left Atrial Appendage Occluder consists of an Umbrella and a Cover connecting with each other by a Connecting Sleeve. The Umbrella is made of a nitinol elastic framework with hooks on it to secure the device to the walls of left atrial appendage (LAA).The Cover is made of a nitinol elastic mesh shaped into a flat disc with a recessed hub located at the middle for connecting to the Delivery Cable, which is used to advance the LAA occluder through the Delivery Sheath to the intended position. Both of the Umbrella and the Cover are sewn with PET membranes to prevent entry of blood into LAA after placement. The Delivery System comprises a Delivery Sheath, a Dilator, a Delivery Cable, a Loader and two Haemostatic valves.

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