Take a moment to explore the advanced functionalities
Designed for Excellence in ECP
The THERAKOS™ CELLEX™ Photopheresis System is the world’s only fully integrated and validated ECP system1.
EFFICIENCY & REASSURANCE
CELLEXTM System average treatment time1
Single-needle mode: 103.0 mins
Double-needle mode: 74.4 mins
Reassurance for physicians and operators, comfort for the patient
Flexibility of switching between single- or double-needle modes during the procedure1
Enables adapting to the patients’ venous access conditions
Peristaltic pumps provide smooth vein pressure4
Gives confidence to you and comfort to your patients
Because your patient remains connected throughout the procedure:
Minimal re-infusion errors and risk of cross-contamination2,3
Minimal risk of microbial contamination2,3
1. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169. 2. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 3. Perotti C, Sniecinski I. Transfus Apher Sci. 2015;52(3):360-368. 4. Operator’s Manual. THERAKOSTM CELLEXTM Photopheresis System. Therakos. 2019.
Versatility
CELLEXTM System provides the versatility to treat a wide range of patient types
Vascular access
Choice of single- or double-needle mode and ability to switch between the two according to venous access conditions
Different disease states
Spectrum of white blood cells is collected, making treatment applicable to various disease states
Abnormal lipid and bilirubin in plasma
Bowl optic sensor allows customisation of the system to the needs of abnormal plasma conditions
No lower limit for leukocyte levels
Continuous collection and separation enables treatment even with low leukocyte levels
Adjustable to cardiac, pulmonary or renal function
Fluid shifts minimised in double-needle mode
AUTOMATION FOR SIMPLICITY
The CELLEXTM System automatically manages treatment
Automated photosensitising agent dosing calculations help minimise dosage errors1
Specific algorithm for consistent UVA irradiation automatically calculates and sets photoactivation time according to lamp life, % haematocrit and treatment volume1
UVA, ultraviolet A.
1. Operator’s Manual. THERAKOSTM CELLEXTM Photopheresis System. Therakos. 2019.
Adjusting to the patient
CELLEX™ System automatically controls collection
Bowl optic sensor automatically identifies the red cell layer1
Allows automated adaptation to the patient’s plasma conditions and delivery of a consistent buffy coat
Automated flow rate controls
reduce the need for operator interventions1
Haematocrit sensor provides automated detection of haematocrit1
Automatically determines when buffy coat collection should end and final data automatically informs photoactivation time
1. Operator’s Manual. THERAKOSTM CELLEXTM Photopheresis System. Therakos. 2019.
Unique characteristics
Key features of the CELLEX™ System
The world’s only fully integrated and validated platform for ECP1
Single, uninterrupted
sterile fluid path
Automated flow rate controls2
Minimises the need for operator intervention
Fully integrated and validated technology
One technology interface
(integrated touchscreen)
One kit (single/double needle) for all procedures
Single contact for procedural
reporting
Compact mobile system, easily moved if required*
*Contact your Therakos representative if you intend to move the CELLEX™ device within your unit.
ECP, extracorporeal photopheresis.
1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. Therakos. 2019.
INTEGRATED AND VALIDATED TECHNOLOGY
The CELLEXTM System allows you to treat patients with integrated and validated technology.
Use of bespoke combinations of separate instruments for ECP constitutes “off-label” use
The treatment decision and justification rests with the physician or treatment centre1-3
EU regulation supports use of devices outside their Instructions For Use only if an equivalent approved device is not available on the market4
ECP, extracorporeal photopheresis; EU, European Union.
1. European Directorate for the Quality of Medicines & Healthcare (EDQM). Guide to the quality and safety of tissues and cells for human application. 3rd ed. 2017. 2. European Council. Council Directive 85/374/EEC. 3. Notified Bodies Medical Devices (NB-MED). Recommendation NB-MED/2.5.1/Rec5. 4. European Parliament and European Council. Regulation EU 2017/745.
FULLY INTEGRATED & VALIDATED
European patent1
Cassette for controlling the movement of blood and separated blood components
EC Declaration of Conformity2,3
Medical Device Directive 93/42/EEC
Can be used safely with the materials, substances and gases with which they enter into contact
Performance is maintained in accordance with the intended use
CE 27974
Design, development and manufacture of the THERAKOS™ CELLEX™ Photopheresis System (including the Instrument, Light Assembly and Procedural Kits)5
ISO 13485:2016 & EN ISO 13485:2016 certified*3
Therakos Quality Management System (certified for the design, manufacture, distribution and service of Photopheresis System)
*Certified by a Notified Body (BSI Certificate of Registration number MD 665632).3
BSI, British Standards Institution; CE, Conformité Européene; EC, European Council; ISO, International Organization for Standardization.
1. European Patent Office. EP1512420B1. March 9, 2005. Available at: https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20081119&DB=&locale=en_EP&CC=EP&NR=1512420B1&KC=B1&ND=4. Accessed February 2022. 2. European Council. Council Directive 93/42/EEC. 3. Therakos (UK) Ltd. Data on file - ref-04301. 4. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 5. Therakos (UK) Ltd Data on file Ref 06130.
Get to know the ECP procedure with the CELLEXTM System
The procedural steps3
- The instrument collects a small fraction of blood from the patient
- The blood is separated by centrifugation
- Red blood cells and plasma are returned immediately to the patient
- Methoxsalen* is added to the buffy coat fraction† and cells are photoactivated by ultraviolet A light
- The photoactivated buffy coat fraction† is reinfused to the patient
Please refer to the appropriate operator’s manual for further details prior to prescribing ECP therapy.
*Exact mechanism of action (MoA) of the photosensitising agent is unknown.
†The buffy coat fraction of a whole blood sample following centrifugation contains most of the white blood cells and platelets.
ECP, extracorporeal photopheresis; UVA, ultraviolet A.
References:
1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Therakos (UK) Ltd. Data on File – ref-05174. 3. Operator’s Manual. THERAKOSTM CELLEXTM Photopheresis System. Therakos. 2019
Already have the CELLEXTM System?
Get the most out of your device and visit our new Therakos e-learning platform
