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 at any time during the procedure

Enables adapting to the patients’ venous access conditions1

Peristaltic pumps provide smooth vein pressure4

Gives confidence to you and comfort to your patients

Because your patient remains connected throughout the procedure:

Minimised re-infusion errors and 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. 2014;28 Suppl 1:1-37. 3. Perotti C, Sniecinski I. Transfus Apher Sci. 2015;52(3):360-368. 4. Therakos, Inc. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. Available at: https://www.mallinckrodt.ca/wp-content/uploads/2018/08/Operators-Manual.pdf. Accessed October 2019.

Versatility

CELLEXTM System provides the versatility to treat a wide range of patient types

Vascular access

Choose/switch between single- or double-needle mode according to access conditions

Different disease states

Full spectrum of white blood cells collected and treated

Abnormal plasma lipid or bilirubin

Accommodated through system customisation

Low leucocyte levels

No lower limit for treatment

Cardiac, pulmonary or renal issues

Fluid shifts minimised in double-needle mode

1. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169.

AUTOMATION FOR SIMPLICITY

CELLEXTM System helps you manage treatments

Automated 8-MOP dosage
calculation
helps minimise dosage errors1

Specific algorithm for consistent UVA irradiation automatically calculates and sets photoactivation time according to lamp life, % haematocrit and treatment volume1 and helps minimise “burning” cells

The combination of CELLEX™ System and “lean” working practices has resulted in a 50% increase in patient treatments2 – all with the same number of nurses employed in the unit.2

1. Therakos, Inc. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. Available at: https://www.mallinckrodt.ca/wp-content/uploads/2018/08/Operators-Manual.pdf. Accessed October 2019. 2. Linic B, et al. The implementation of ‘lean’ working practices and THERAKOS™ CELLEX™ have resulted in a 50% increase in patient treatments with the same number of nurses employed in the unit. Presented at the 20th congress of the European Hematology Association; 11–14 Jun, 2015, Vienna, Austria. Poster E1428.

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 informs photoactivation time

1. Therakos, Inc. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. Available at: https://www.mallinckrodt.ca/wp-content/uploads/2018/08/Operators-Manual.pdf. Accessed October 2019.

Unique characteristics

Unique characteristics of the CELLEX™ System

Completely “closed”
and integrated (in-line),
continuous “one-step” process1,2

Single, uninterrupted
sterile fluid path

Fully automated1,3,4

Minimises the need for operator intervention

Full integration into one mobile, compact system

One technology interface
(integrated touchscreen)

One kit (single/double needle) for all procedures

Single contact for procedural
reporting

Easily moved if required

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-37. 2. Bobhot A, et al. A multi-centre cost comparison of integrated versus “offline” systems for performing extracorporeal photopheresis procedures. Presented at the 20th congress of the European Hematology Association; 11–14 Jun, 2015, Vienna, Austria. Poster E1431. 3. Perotti C, Sniecinski I. Transfus Apher Sci. 2015;52(3):360-368. 4. Therakos, Inc. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. Available at: https://www.mallinckrodt.ca/wp-content/uploads/2018/08/Operators-Manual.pdf. Accessed October 2019.

Validated performance for ECP

The CELLEXTM System allows you to treat patients with validated performance of the 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

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. Available at: https://www.edqm.eu/en/organs-tissues-and-cells-technical-guides. Accessed October 2019. 2. European Council. Council Directive 85/374/EEC. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31985L0374&from=EN. Accessed October 2019. 3. Notified Bodies Medical Devices (NB-MED). Recommendation NB-MED/2.5.1/Rec5. Available at: http://www.meddev.info/_documents/R2_5_1-5_rev4.pdf. Accessed October 2019. 4. European Parliament and European Council. Regulation EU 2017/745. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745. Accessed October 2019.

FULLY INTEGRATED & VALIDATED

European patent1

Cassette for controlling the movement of blood and separated blood components

EC Declaration of Conformity2

Medical Device Directive 93/42/EEC3

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)3

ISO 13485:2003 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

1. European Patent Office. EP1512420B1. March 9, 2005. Available at: https://worldwide.espacenet.com/publicationDetails/biblio?II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=20050309&CC=EP&NR=1512420A2&KC=A2#. Accessed January 2020. 2. Therakos (UK) Ltd. Data on file. BSI. Certificate of Registration. Quality Management System – ISO 13485:2016. No. 72801. February 1, 2018. 3. European Council. Council Directive 93/42/EEC. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN. Accessed February 2019. 4. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-37. 5. Therakos (UK) Ltd. Data on file. BSI. EC Certificate – Full Quality Assurance System. No. CE 00360. April 7, 2017.

Get to know the ECP procedure with the CELLEXTM System

The procedural steps

  • 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 of methoxsalen is unknown.
The buffy coat fraction of a whole blood sample following centrifugation contains most of the white blood cells and platelets.