EXTRACORPOREAL CIRCULATION KITS - OTHER

Primary DI

08056045290120

Basic UDI-DI Code

805604529KITPROLUNGS2

Reference

PLAQUA3D

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

ProLUNG® 3D CO2 removal device is intended for use in a veno-venous extracorporeal circulation system for blood CO2 partial removal in patients with acute respiratory failure. LF- ECCO2R support is an extracorporeal circulation technique used to temporarily assist the pulmonary functions in gaseous exchange of primarily carbon dioxide and partly oxygen. This technique can be applied to patients affected by acute respiratory failure not manageable with the sole aid of mechanical ventilation (pulmonary ventilator). The use of the blood CO2 partial removal system allows the use of non-invasive ventilation techniques (NIV) or the adoption of protective invasive mechanical ventilation (IMV with low Tidal Volume) reducing pulmonary stress and allowing a partial rest condition of the patient’s lungs. The technique provides for treatment at low blood perfusion flows with high gas flow rates, applied to remove a high concentration of CO2, which in relation to the systemic blood concentration determines a progressive reduction of the total venous blood CO2 to acceptable values. For these applications a blood-gas exchanger with a low priming volume, high performance, and low resistance of the gas compartment is required. The ProLUNG® 3D device has all these characteristics, associating a reduced priming volume, thanks to the absence of a heat exchanger, not required in low flow extracorporeal circulation guaranteeing high performance gas exchange. Maximum treatment period: 3 days.

ProLUNG® 3D CO2 removal device is intended for use in a veno-venous extracorporeal circulation system for blood CO2 partial removal in patients with acute respiratory failure. LF- ECCO2R support is an extracorporeal circulation technique used to temporarily assist the pulmonary functions in gaseous exchange of primarily carbon dioxide and partly oxygen. This technique can be applied to patients affected by acute respiratory failure not manageable with the sole aid of mechanical ventilation (pulmonary ventilator).

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