German based LIFEBRIDGE AG receives FDA clearance for mobile LIFEBRIDGE

Oct 26 2009

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.