Surgeons regularly face problems during cancer surgery:
Tumour cells
left undetected
Healthy tissues
unnecessarily resected
Operative workflows
are complex
Marginum HIVEN® enables unforeseen manual control for detection of tissues:
Device: HIVEN® Aspirate Tissue Detector, risk Class IIb (EU MDR Certified)
UDI-DI: 06429810994004
Manufacturer: Marginum Ltd, Åkerlundinkatu 8, 33100 Tampere Finland
Intended use: HIVEN® device is intended for tissue fluorescence detection during fluorescence-guided surgical operations for suspected high-grade gliomas in which 5-aminolevulinic acid (5-ALA) is used. The device is used for detecting fluorescence of flowing tissues within a transparent tube and providing auditory feedback of tissue fluorescence for neurosurgeons. There is no patient contact intended with this device.
The patient benefit from using the device is increased detection of fluorescence during surgery. The detection of fluorescence has been shown to lead to more complete resection of tumour and improved progression-free survival.
Refer to the instruction manual. Training is mandatory for first-time users.
Precise detection
of tissue fluorescence
Minimal damage
to healthy tissues
Simplified workflow
at all times
All Marginum products and the quality management system comply with the applicable requirements of the Regulation (EU MDR) 2017/745. Our Quality Management System is also certified according to the standards ISO 13485:2016 and EN ISO 13485:2016.
Effortless, near real-time operating MARGINUM® device monitors the surgical suction fluids’ content and analyses the intensity of tissue fluorescence.
The surgeon is informed, if any traces of fluorescent tissue are present in the resected tissue with truly objective and precise feedback. The device platform utilises FLUOSIGHT® software suite for accurate measurement.
Effortless to use
Hardware-fixed interface with audio feedback from analysis
Design utilises streamlined materials & production is planned with minimal carbon footprint
Integrates seamlessly to existing workflow
Technically failsafe
Highly sensitive & specific analysis
Automated operation