FLUXMEDICARE® is a medical device intended for the treatment of actinic keratosis by photodynamic therapy (PDT).
FLUXMEDICARE® is revolutionising skin precancer treatment by greatly reducing the pain felt by patients.
Actinic keratoses are mainly located on the face, scalp and back of the hands. They are pre-cancerous skin lesions which are generally caused by unprotected exposure to the sun. Conventional photodynamic treatment is painful for patients.
Composed of a laser source and a fibre-optic based light emitting, FLUXMEDICARE® is revolutionising PDT treatment conditions due to its innovative light diffusion technology.
Exclusive technology for treating pre-cancer of the skin
Exclusively developed by MDB Texinov®, which specialises in technical textiles for the medical field, the fibre optic-based FLUXMEDICARE® luminous textiles use a patented knitting procedure. This innovative photodynamix therapy promotes :
light intensity :
Unprecedented intensity obtained as a result of the density of the fibre optics and their arrangement in the knit
Extreme textile flexibility :
Making it perfectly easy to handle and shape the patient’s body
Textiles in multiple formats
For the various areas to be treated.
Almost no heat given off
- Technology : 2M laser diode
- Wavelength : 638 nm (red light)
- Light dose : 12 J/cm²
- Irrradiance : 1,3 mW/cm²
- Exposure time : 2 hours 30 minutes
- Service life : 5000 hours
- Protection : IpX0
- Power supply : 220 to 240 VAC; 50/60 Hz
The clinical study
The FLUXMEDICARE® solution was developed as an extension to the European project ”Phos-Istos “ (FP7-CIP-ICTPSP-2013.3.5) drawn up in partnership with INSERM in Lille (U 1189 – Laboratoire OncoThAI), the CHRU de Lille (France) and Klinikum Vest Recklinghausen (Germany).
The official publication of the clinical trials is available from the “British Journal of Dermatology” :
- Mordon, S., et al., The conventional protocol versus a protocol including illumination with a fabric-based biophotonic device (the Phosistos protocol) in photodynamic therapy for actinic keratosis: a randomized, controlled, non-inferiority clinical study. Br J Dermatol, 2019.
The FLUXMEDICARE® system is composed of a knitted textile into which are inserted fibre optics connected to a laser light source for dermatology applications. It is a Class IIa medical device in accordance with Directive 93/42 EEC manufactured by MDB Texinov® which has had a conformity assessment performed by the BSI body.
It is intended for health professionals in the context of treatment for certain dermatological conditions (thin, non-pigmented actinic keratoses of OLSEN Grade 1 and 2). Please read the instructions for use carefully.
Class / Notified body : IIa / CE 2797
Manufacturer : MDB Texinov®
To use this product correctly it is recommended that the indications and contraindications listed in the Product Instructions for Use are followed.
WHERE CAN YOU FIND Fluxmedicare®?
FLUXMEDICARE®, treatment for pre-cancer of the skin, is available in Europe through a network of specialised distributors to health professionals (dermatologists, hospital centres, clinics, and laser centres).
Are you a dermatologist, oncologist, medical device distributor, etc.? Are you interested in a demonstration of the FLUXMEDICARE® device or represent it?
Contact us using the form below for any further information.