The FDA has granted 510(k) clearance to Maquet Cardiovascular for its Cardiohelp system, a small, portable heart-lung support system that provides extracorporeal life support. The approval will allow the system to be marketed throughout the U.S.
Wayne, N.J.-based Maquet said that the system incorporates an HLS Advanced Tubing Set and is the first system of its kind to be approved for both air and ground transportation, and will give support to both heart and lung failure patients.
Cardiohelp offers support to patients who require either veno-venous or veno-arterial life support and can also be used during open heart surgery for extracorporeal CO 2 removal up to six hours. The company said the system’s rechargeable battery can operate for 90 minutes without an external power supply and its touch screen and rotary knob provides ease-of-use to medical personnel.
The system can also monitor venous oxygen saturation, hemoglobin, hematocrit and arterial and venous blood temperatures and its sensor system that includes three pressure sensors is integrated into the HLS Module Advanced disposable. Lastly, Cardiohelp can be configured to capture case data and data recording intervals can be set from three to 10 seconds.
The company said that it expects marketing to begin later this year.