Medical device firm CardiacAssist has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new TandemLung oxygenator.
TandemLung oxygenator serves as an artificial lung to infuse oxygen and remove carbon dioxide from the blood.
The device is intended for use in adult patients for extracorporeal circulation during cardiopulmonary bypass for up to six hours.
When coupled with the company’s TandemHeart blood pump, the new oxygenator acts as a leap forward in extracorporeal life support (ECLS) technology for patients in need of critical cardiopulmonary care.
TandemLung features low priming volume and patent-protected radial flow technology, which allows the device to be deployed rapidly to protect patients from the negative effects of diminished cardiac or respiratory function.
CardiacAssist president and CEO John Marous said: "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."
CardiacAssist said that around 300,000 patients experience an acute cardiac or respiratory event every year in North America.
Image: CardiacAssist’s new TandemLung oxygenator. Photo: courtesy of CardiacAssist, Inc.