State of Development
The LIFEBRIDGE B2T® is not yet FDA approved.
January 2008 – The LIFEBRIDGE B2T® has cleared the stringent test hurdles necessary for CE certification including requirements according DIN EN 1789 (= mobile use in ambulances) and therefore satisfies all safety requirements prescribed for a mobile emergency heart and lung support system. As a result, the company has set a new medical engineering-industry standard in emergency medicine!
In close collaboration with TÜV Product Services GmbH in Munich, Germany, one of the leading licensing institutions in this special medical-engineering field, the complex requirements to be placed on the system in terms of safety were identified and successfully implemented in the product development of the LIFEBRIDGE B2T®.
Up until the present time, the technology of conventional heart-lung machines has been designed exclusively for elective use in operating theatres. Routine applications under emergency conditions and outside this strictly controlled environment were until now confronted with insurmountable problems of system safety (e.g. in the protection against air embolism) and ease of operation, essential under these circumstances. Meeting these essential and demanding requirements posed special challenges to the technical development of the LIFEBRIDGE B2T®.
With the CE certification the clinical introduction of the system has started in Europe.
The LIFEBRIDGE B2T® is not yet FDA approved.
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