US 510(k) clearance for Macquet's Cardiohelp system
This article was originally published in Clinica
The US FDA has granted 510(k) clearance for the Cardiohelp system developed by Maquet Cardiovascular. The Cardiohelp is the world's smallest portable heart-lung support system providing extracorporeal life support to replace or support a patient's circulation and respiration. US launch is expected later this year, Wayne, New Jersey-based Maquet said. The Cardiohelp can be used as a cardiac and/or respiratory assist device for up to six hours. It is the first support system approved for both ground and air transportation, and allows blood parameters to be monitored during life support, ensuring the patient's safety.