German medical devices maker Hemovent has secured CE marking for its Mobybox extracorporeal life support (ECLS) system, enabling the company to sell the product across the European Union.
Mobybox is a miniaturised heart/lung machine, which uses the company’s Bionique flow technologies as its platform.
Bionique flow technologies will provide a variety of opportunities to enhance safety, efficacy, performance and ease of use to create fundamentally new ECMO and ECLS solutions, said the company.
Mobybox, which is claimed to be the world’s first self-contained and fully integrated ECLS system, will help replace heart and lung function in the event of cardiac and/or respiratory failure.
Hemovent co-founder and CEO Christof Lenz said: “We will commence immediately with the roll-out of our initial product MOBYBOX in a phased approach among various centers of excellence in Europe.
“Given our recent announcement of the closing of our Series B financing round, we have the financial resources in place to be immediate and steadfast in executing our product launch.”
According to the company, ECLS patients are found in multiple treatment settings, which require a flexible system configuration.
The pneumatic drive line of Mobybox system will enable easy separation of the patient unit from the controller.
Mobybox is suitable for situations with limited infrastructure such as emergency applications in the field or during transport, as it does not require an electrical power source.
The system facilitates patient mobilisation, specifically during ambulation, as its individual components can be separated and positioned individually.
The patient unit can be placed at the patient’s bedside, even during prone positioning and mobilisation.
Hemovent chief technology officer Dr Oliver Marseille said: “MOBYBOX is designed to make high-end critical care for heart and lung support much safer and simpler to use. In doing so, MOBYBOX has the potential to help more than two million patients worldwide annually who suffer from acute cardiac and respiratory failure.”
Hemovent is an emerging medical device company, which has a platform technology for heart and lung support.