Novel Cardio-Pulmonary Support Device LIFEBRIDGE(R) From Germany Gains FDA
Clearance
LIFEBRIDGE Medizintechnik gets Go-ahead on the US Market
AMPFING, Germany, October 26 /PRNewswire/ -- German based LIFEBRIDGE AG
has received clearance from the U.S. Food and Drug Administration (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(R) available for use
as a cardiopulmonary support system in the important US market as well.
Weighing a mere 38.5 lbs (17.5kg), the LIFEBRIDGE can be used to assume the
function or the heart and lungs anytime, anywhere. Even on battery power.
This allows the patient to receive oxygen and circulatory support even during
the most critical situations.
The LIFEBRIDGE(R) provides novel therapy that can be used by
cardiologists, cardiovascular surgeons and ER physicians to treat patients in
immediate need of cario-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. The
LIFEBRIDGE(R) can provide full heart and lung support even when operating on
battery power.
The LIFEBRIDGE is the first compact, mobile heart lung machine cleared by
FDA.
We are aware of the interest of our American colleagues and plan to
introduce this life-saving technology to key US centers soon, states Michael
Huf, Head of Sales and Marketing Worldwide, LIFEBRIDGE Medizintechnik.
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(R) 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.
The LIFEBRIDGE(R) contains an automatic seven stage air safety system
preventing air embolisms.
Press contact:
HighTech communications GmbH
Heike Mittmann
Grasserstrasse 1c
80339 Munich
Telephone: +49(0)89-500-778-20
Telefax: +49(0)89-500-778-77
E-Mail: h.mittmann@htcm.de
http://www.htcm.de
SOURCE LIFEBRIDGE Medizintechnik AG
Press contact: HighTech communications GmbH, Heike Mittmann, Grasserstrasse
1c, 80339 Munich. Telephone: +49-(0)89-500-778-20, Telefax:
+49-(0)89-500-778-77, E-Mail: h.mittmann@htcm.de
