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LIFEBRIDGE® – the world’s first CE certified and FDA cleared portable extracorporeal life support system

Every Year in Germany alone, some 20,000 people still die of cardiovascular failure following severe myocardial infarction or of a consequential cardiogenic shock. Only 30 to 50% of the affected patients survive this grave complication, which 7 to 10% of them suffer, after hospitalisation in most cases, within the first 30 days after the infarction incident. During diagnostics in the catheter laboratory, on the way there, or during revascularisation intervention, the reduced circulatory performance will impair the whole organism over and above the cardiac problem; this results in retarded recovery or even irreversible multiple organ damage due to prolonged oxygen deficiency.

Precious time gains and secure transport

For this reason, employing the world’s first approved mobile cardiopulmonary support system for emergencies and transport can have a direct positive effect on the chance of survival in cases of acute cardiovascular failure or severe myocardial infarction. As early as during diagnostics and initial cardiac treatment the organism will experience a vital reperfusion phase. Within a few minutes, the CE certified LIFEBRIDGE^® will stabilise the patient’s condition as an extracorporeal circulatory support and can assume the functions of the heart and lung completely in emergency situations. Whether when moving patients from a primary treating hospital lacking cardiac surgery to a specialised clinic or as a backup system for invasive diagnostics and interventional therapy in catheter laboratories, the LIFEBRIDGE^® provides reliable cardiovascular support to avoid consequences of shock.

Emergency medical aid on location by trained medical staff

Measuring only 24” x 18” x 15” (61 x 45 x 37 cm – W x H x D) and weighing not more than 38.5 lbs (17.5kg), the LIFEBRIDGE^® can be carried by one person and is ideally suited for transporting in ambulances and helicopters. Owing to its unique level of automation, the system is ready for use within 5 – 10 minutes and guides the trained attending physician intuitively through the menu on the integrated display in five steps. This simple and safe way of operating the system eliminates the need for a perfusionist when attaching it to a patient, which is done with the help of a venous and an arterial femoral cannula. The LIFEBRIDGE^® reaches a blood flow of up to 6 l/min and is powered by 110/220VAC mains voltage. For mobile operation, the system can be switched to battery power for a period of up to 2.5 hours under average load.

A unique, patented safety concept offers protection against air embolisms

The LIFEBRIDGE^® features a seven stage air removal safety system preventing air embolisms reliably in a fully automatic way. All replaceable “patient modules” with encapsulated components that come into blood contact directly are disposed of by the hospital after use. In 2008, a clinical study conducted for the CE approval process revealed the equivalence of the miniaturised mobile cardiopulmonary support system to conventional heart-lung machines. The purchase cost of the LIFEBRIDGE^® of under 50,000 Euros amounts to no more than a third when compared to these. Operating costs per patient treatment amount to 3,000 to 3,500 Euros.

Support with OPS coding and reimbursement

For all currently active centres in Germany, it was possible to work out satisfactory reimbursement options with Lifebridge Medizintechnik that also withstood auditing by the MDKs (Medizinischer Dienst der Krankenversicherungen – health insurances’ medical services). Reimbursement is effected either by means of an additional fee agreed upon for the particular hospital or directly via the DRG (Diagnosis Related Groups) system. For negotiations with cost bearers, Lifebridge Medizintechnik will provide documents for real cost calculation, OPS coding help, and real-life example cases.

LIFEBRIDGE^® – proven in more than 200 use cases

“We are proud that in Germany alone, more than 40 hospitals have decided to employ the LIFEBRIDGE^® following its market launch in early 2008 and have brought it to use successfully for more than 200 patients. 70% of those cases can be classified as acute emergencies!”, declares Michael Huf, Head Sales and Marketing Worldwide der Lifebridge Medizintechnik AG, and continues, “With our successful FDA clearance in October of 2009 we have overcome another high barrier, making us the first manufacturer with a go-ahead for launching the LIFEBRIDGE^® in the United States as well. As yet, no comparable other product has approvals for real-life use, providing all the more evidence for the technological lead and the pioneering role of our company in mobile cardiopulmonary support. We are well aware of the great interest of our American colleagues and plan to be on location with the LIFEBRIDGE^® in some of the leading US clinics to help save lives within the coming weeks.”