CardiacAssist said today it won FDA 510(k) clearance for its TandemLung oxygenator designed to operate as an artificial lung by infusing oxygen and removing carbon dioxide from the blood.
The Pittsburgh, Penn.-based company said the TandemLung is designed so it can be used along with its TandemHeart blood pump, and combined the devices “represent a leap forward in extracorporeal life support technology for patients in need of critical cardiopulmonary care.”
“After our original TandemHeart pump was cleared for use with an oxygenator in 2011, our team immediately began working with experts in the field to understand how to reduce the complexity of cardiopulmonary bypass technology so that more patients could receive this potentially life-saving procedure. The design of the TandemLung is a direct result of those efforts. This release represents our 6th new product clearance since September 2013, and we are proud to dedicate ourselves to improving the lives of patients by delivering innovative, easy-to-use devices for simplified life support,” CEO John Marous said in prepared remarks.
CardiacAssist said that only a small portion of the more than 300,000 patients who experience an acute cardiac or respiratory event that requires emergency intervention receive advanced life support like its Tandem products, due to the complexity of deploying the technology. The company said its TandemLung was designed for simplicity and performance to make ECLS faster and more accessible.
Last April, CardiacAssist 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 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.