FDA Approves Tandemlung Oxygenator for Extracorporeal Life Support

People with life-threatening respiratory or cardiac failure depend on extracorporeal life support (ECLS), a medical device that acts as an artificial lung for breathing. But only limited percentage of patients are provided with ECLS due to its complexity.

Now, the Food and Drug Administration (FDA) has approved the TandemLung oxygenator of the company CardiacAssist. The medical device helps in infusing oxygen and removing carbon dioxide from the blood.

‘CardiacAssist won FDA clearance to introduce its TandemLung oxygenator, a device that can perform blood oxygenation and efficient CO2 removal for extracorporeal life support. ’

When this device is paired with the already approved CardiacAssist's TandemHeart blood pump, it represents a leap forward in extracorporeal life support technology for patients in need of cardiopulmonary care.

The device utilizes an optimized radial flow design coupled with advanced polymethyl pentene (PMP) fibers to transfer oxygen into the blood for patients requiring cardiac or respiratory support. It is intended for use in adult patients for extracorporeal circulation during cardiopulmonary bypass for up to 6 hours.

Its advantages include low priming volume and patented radial flow technology that helps in faster initiation of oxygenation. This optimized design for simplicity and performance has assisted in making ECLS quicker and more accessible.

"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," said John Marous, President and CEO of CardiacAssist.

Source: Medindia