CardiacAssist last week said it nailed down CE Mark approval in the European Union for a cannula designed to both drain and re-infuse blood during life support procedures.
The Pittsburgh-based company said the Class 3 CE Mark covers its Protek Duo veno-venous cannula, a thin tube that’s inserted into a jugular vein to drain fluid and reinfuse blood during life support procedures for patients with acute respiratory distress syndrome.
CardiacAssist said the Protek Duo can be used with its TandemHeart extracorporeal life support pump, which is placed directly on the patient and can give up to 30 days of circulatory support.
Last May, the company got into hot water with the FDA over the TandemHeart device, after inspections found that CardiacAssist failed to file a report after a patient death. The patient died while on TandemHeart when the pump stopped turning after 10 days and attempts to restart it were unsuccessful, according to the safety watchdog’s warning letter.
CardiacAssist’s response was deemed sufficient to address the violation, the FDA said.
