FDA Clears Abiomed’s Cardiopulmonary Bypass System

The FDA has granted Abiomed 510(k) marketing clearance for its Abiomed Breethe OXY-1, a compact cardiopulmonary bypass system.

The system oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass procedures for up to six hours and can help patients with cardiogenic shock — when the heart cannot pump enough blood and oxygen to the brain, kidneys and other vital organs — or with respiratory failure caused by COVID-19, SARS, H1N1 and acute respiratory distress syndrome.

The system must be operated or monitored by users with specialized training in extracorporeal circulation therapy.