THERAKOSTM CELLEXTM Photopheresis System

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 Mark4

Design, development and manufacture of the THERAKOS™ CELLEX™ Photopheresis System (including the Instrument, Light Assembly and Procedural Kits)

ISO 13485:2016 certified*5

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 FM 72801).5

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-05185. 4. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 5. Therakos (UK) Ltd. Data on file - ref-05184.

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

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