SENTANTE™

Primary DI

04779060520105

Basic UDI-DI Code

477906052SENTANTEF3

Reference

SEN-01

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

UAB Inovatyvi Medicina

The complete SENTANTE system comprises the following main functional units: - Remote Workstation; - Bedside Unit; - Cart; - Nurse’s Workstation. The SENTANTE system can manipulate up to three endovascular devices simultaneously (e.g. a guidewire and two over-the-wire (OTW) catheter-based devices) one inside the other. The System is controlled via conventional endovascular devices as the user interface. The SENTANTE system senses movements in the interface devices and replicates the same movements to the devices that are being manipulated inside the vessels. The System also detects the resistance of the devices inside the vessels and provides haptic force feedback to the user through the interface devices. This enables users to perceive and feel the resistance of endovascular devices comparable to what they would encounter while manually manipulating the devices within the vessels.

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