Development, manufacturing, distribution and service of the mobile heart-lung support system LIFEBRIDGE®.
LIFEBRIDGE Medizintechnik AG
Ampfing (Headquarters)New on Amplifa
About LIFEBRIDGE Medizintechnik
LIFEBRIDGE Medizintechnik AG, headquartered in Ampfing (Bavaria), develops, manufactures, distributes and services mobile systems for heart-lung support. The company was founded in 1999 and, in collaboration with German and international scientists and physicians, developed the first mobile heart-lung machine. The LIFEBRIDGE B2T® system completely takes over the functions of the heart and lungs in cases of acute circulatory failure; weighing 17,5 kg and measuring 61 × 45 × 37 cm, it can be carried by a single person and is suitable for use in rescue vehicles and helicopters. It is connected percutaneously to the patient's circulatory system and serves primarily for short-term cardiopulmonary bridging in acute heart failure. The system has been in clinical use since 2008, in more than 40 European hospitals, and is approved for emergency medicine, intensive care units, cardiac catheterization laboratories and patient transport. The scope of services also includes a training program for medical staff on operating the system.
- Site
- Ampfing
- Processes
- Development, manufacturing, distribution and service of mobile heart-lung support systems, Training program for medical staff on operating the system
- Materials
- LIFEBRIDGE B2T® (mobile heart-lung machine)
- Certificates
- DIN EN ISO 13485, CE certification according to Annex II of EU Directive 93/42/EEC (MDD), FDA approval (USA), DIN EN ISO 13485 (TÜV SÜD Product Service), CE certification according to MDD Annex II
- Founded
- 1999
- Industries
- Medical Technology, Emergency Medicine, Cardiology
- 01
Development
- 02
Manufacturing
- 03
Distribution
- 04
Service
- 05
Training of medical staff
Technical Equipment
LIFEBRIDGE B2T® (mobile heart-lung machine)
Portable system for extracorporeal heart-circulatory support with integrated safety mechanisms against air embolisms and exchangeable patient modules.
Locations
Ampfing
DEHeadquarters with development, manufacturing, distribution and service
- Part weight / size
- System: 17,5 kg, 61 × 45 × 37 cm
- LIFEBRIDGE B2T®: blood flow up to 6 L/min, mains operation 110/220 V (AC), battery operation up to approx. 2.5 hours at average load
Industries
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Mobile heart-lung machine (own product, not a production system) | LIFEBRIDGE Medizintechnik AG LIFEBRIDGE B2T® | – | Dimensions 61 × 45 × 37 cm (W × H × D), blood flow up to 6 L/min, mains operation 110/220 V (AC), | – | Ampfing, Bavaria |
Additional services
Reference customers
Quality
The quality management system is certified by TÜV SÜD Product Service according to DIN EN ISO 13485 and according to Annex II of EU Directive 93/42/EEC (MDD); a Head of Quality Management coordinates quality assurance.
| Evidence | Ampfing |
|---|---|
| DIN EN ISO 13485 (TÜV SÜD Product Service) | |
| CE certification according to MDD Annex II | |
| FDA approval (USA) |
History
- 1999
Foundation of LIFEBRIDGE Medizintechnik AG in Ampfing (Bavaria); development of mobile heart-lung support systems
- 2008
CE approval for use in emergency medicine, intensive care units, cardiac catheterization laboratories and transport; clinical use of the LIFEBRIDGE B2T® from early 2008
- 2009
FDA approval since October 2009
- 2011
Certification by TÜV SÜD Product Service according to MDD Annex II and DIN EN ISO 13485
- 2012
National winner in the Business category at '365 Orte im Land der Ideen'