Hemovent GmbH announced today that it won CE Mark approval for its Mobybox Runner controller for heart and lung support.
The Mobybox is a miniaturized heart and lung machine designed to improve safety, ease of use, mobility and performance for supporting heart and lunch health. It utilizes the company’s Bionique Flow technologies used for gentle extracorporeal perfusion and oxygenation with the least possible impact on natural blood and cell physiology.
Hemovent also touts the Mobybox as the first self-contained and fully integrated extracorporeal life support (ECLS) system to hit the market.
The Runner controller is a small device designed to manage both blood and gas flow through the Mobybox with just two control knobs. Hemovent said it is planning for a post-market clinical follow-up trial for the device as well.
“With the Runner EU regulatory approval we have created an entirely new solution for the extreme challenges of ECLS deployment in situations with unpredictable and severely restricted emergency environments,” Hemovent co-founder & CTO Oliver Marseille said in a news release.
“The Runner is designed to slingshot clinicians into a new era of mobility and ease of use: Rather than bringing their patient to ECLS, the MOBYBOX with Runner Controller brings ECLS to their patients,” added Hemovent co-founder & CEO Christof Lenz.
Original Article: (https://www.massdevice.com/hemovent-wins-ce-mark-for-mobile-heart-and-lung-support-device/)