Lifebridge gains FDA clearance for cardio-pulmonary support device
15 December 2009
German-based Lifebridge AG has received clearance from the US
FDA for a compact, lightweight, mobile heart-lung machine, a first for
any manufacturer worldwide.
The novel device received CE certification for Germany and Europe in
2008, and now FDA clearance makes the mobile Lifebridge available for
use as a cardiopulmonary support system in the important US market as
Weighing a mere 38.5 lbs (17.5kg), the Lifebridge can be used to
assume the function or the heart and lungs anytime, anywhere. It can
even run on battery power, which allows the patient to receive oxygen
and circulatory support even during the most critical situations.
The Lifebridge provides novel therapy that can be used by
cardiologists, cardiovascular surgeons and ER physicians to treat
patients in immediate need of cardio-pulmonary support.
This device can help stabilize the patient’s condition and can assume
the functions of the heart and lung completely in emergency cases. It
can provide full heart and lung support even when operating on battery
"We are aware of the interest of our American colleagues and plan to
introduce this life-saving technology to key US centres soon," said
Michael Huf, Head of Sales and Marketing Worldwide, Lifebridge
The unique level of automation allows the system to be ready for use
within 5 – 10 minutes and guides the trained user intuitively through
the menu on the integrated display in five steps. The Lifebridge reaches
a blood flow of up to 6 l/min and is powered by a mains voltage of
110/220V AC. For mobile operation, the system can be switched to battery
power for a period of up to 2.5 hours. It contains an automatic seven
stage air safety system preventing air embolisms.