THERAKOS® CELLEX® Photopheresis System

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Purpose-built for photopheresis delivery and designed to meet the needs of you and your patients.

The only all-in-one device, equipped with four wheels and handle for easy transport within your unit.1*
Dimensions: 163 cm x 58.4 cm x 79 cm
Weight: 166 kg
Required Floor Space: 4614 cm2

*Please inform your Therapeutic Area Specialist (TAS) of device location changes within your unit.

Designed for efficiency in ECP administration – specifically developed to deliver ECP immunomodulation.

One kit for each procedure, helping simplify inventory, training and setup.

  • CLXSP-I kits for spike-port bags.

  • CLXCC-I kits for Correct Connect Luer-lock bags

One technology interface, with integrated touchscreen monitoring.

Canada’s only fully-integrated ECP system, designed to enhance ease of use for operators.1

A single-device workflow that eliminates the need to transfer treatment bags between devices from apheresis to photoactivation.

Multiple features to help ensure patients receive safe, adaptable, and well-controlled treatment.

  • Sterile closed system reduces contamination and reinfusion errors, and automated methoxsalen calculations minimize dosage errors.1

  • Approved for use with heparin or Anticoagulant Citrate Dextrose Solution A (ACD-A).

Treatment with the CELLEX system can be completed in as little as 75 minutes, with an average total treatment time* of 99.27 minutes.1-3

High cell collection efficiency, and consistent UVA irradiation set automatically based on remaining lamp lifetime, hematocrit of the treatment bag, and treatment volume.

*Accounts for the buffy coat collection and handling time, the irradiation time, and the handling time after treatment.3

Adaptable features to help optimize treatment for each patient.1

  • Choice of single- or double-needle mode based on venous access, with the flexibility to switch at any time during the procedure.

  • Automated flow rate controls minimize the need for operator intervention.

  • Bowl optic sensor adapts to abnormal plasma conditions, such as lipemia or hyperbilirubinemia.

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Get to know the ECP procedure with the CELLEX® System

  1. The instrument collects a small fraction of blood from the patient
  2. The blood is separated by centrifugation
  3. Red blood cells and plasma are returned immediately to the patient
  4. A photosensitising agent* is added to the buffy coat fraction† and cells are photoactivated by UVA light
  5. 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.

*While much is known about the mechanism of action, the exact mechanism of action is currently being studied.

†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.

Take a moment to explore the advanced functionalities

Experience & Certification

Developing ECP solutions (products, services, and education) since 1987.4

THERAKOS CELLEX Photopheresis Systems have a worldwide reach.5

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Used by >300 treatment centres5

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In >30 countries5

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ECP kits are currently provided to >115,000 patients per year6

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>1.6 million treatments5

Treatment centre information provided is for informational use only, is subject to change, and may not be comprehensive.

THERAKOS® CELLEX® Photopheresis System meets the following global quality standards:

MDR-approved technology7

  • The THERAKOS® CELLEX® Photopheresis System has obtained CE Certification under the Medical Device Regulation (EU MDR) 2017/745, ensuring device safety and efficacy in approved indications.

Restriction of Hazardous Substances Directive (RoHS)1,8

  • New RoHS3 directive-compliant CELLEX® Procedural Kits (CLXSP-I & CLXCC-I kits) comply with the latest RoHS Standard. These kits are available when machines are upgraded to the latest compatible software.

ISO 13485:2016 & EN ISO 13485:2016 certified9*

  • Therakos Quality Management System certified for the design, manufacture, distribution and service of Photopheresis Systems

EC Declaration of Conformity

  • Medical Device Regulation (EU MDR) 2017/745

  • Can be used safely with the materials, substances and gases with which they enter into contact

*Certified by a Notified Body (BSI Certificate of Registration number MD 665632).9

BSI, British Standards Institution; CE, Conformité Européene; EC, European Council; EU, European Union; ISO, International Organization for Standardization.

References: 1. THERAKOS® CELLEX® Photopheresis System Operator’s Manual. 2. Data on File - REF-25-00009. Therakos (Canada) Company. 3. Mayer W, et al. J Clin Apher. 2022;37(4):332-339. 4. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28(suppl 1):1-37. 5. Data on File – REF-26-00320. Therakos (Canada) Company. 6. Data on File – REF-26-00315. Therakos (Canada) Company. 7. Data on file – REF-25-01303. Therakos (Canada) Company. 8. Data on file – REF-25-01057. Therakos (Canada) Company. 9. Data on File – REF-25-01957. Therakos (Canada) Company.

Important Safety Information for THERAKOS® CELLEX® Photopheresis Procedure

INDICATION

The THERAKOS® CELLEX® Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) and systemic sclerosis (SSc).

CONTRAINDICATIONS

Certain underlying medical conditions contraindicate THERAKOS CELLEX Photopheresis, including:

  • Patients who cannot tolerate extracorporeal volume loss during the leukocyte enrichment phase

  • Patients exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds

  • Patients with coagulation disorders or who have had previous splenectomy

WARNINGS & PRECAUTIONS

THERAKOS CELLEX Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure.

  • MR-Unsafe: Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projective injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.

  • Thromboembolic Events: Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD), an indication not approved in Canada. Special attention to adequate anticoagulation is advised when treating patients with GvHD.

  • Concomitant Therapy: When prescribing and administering THERAKOS CELLEX Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

ADVERSE REACTIONS

Hypotension may occur during any treatment involving extracorporeal circulation. Monitor the patient closely during the entire treatment.

Transient pyretic reactions, 37.7-38.9 °C (100-102 °F), have been observed in some patients within 6-8 hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.

Treatment frequency exceeding labeling recommendations may result in anemia.

Venous access carries a small risk of infection and pain.

Important Safety Information for Methoxsalen Sterile Solution Used in Conjunction with THERAKOS® CELLEX® Photopheresis System

CONTRAINDICATIONS

Methoxsalen Sterile Solution is contraindicated in:

  • Patients exhibiting idiosyncratic reactions to psoralen compounds

  • Patients with aphakia

  • Patients possessing a specific history of a light-sensitive disease state

SERIOUS WARNINGS & PRECAUTIONS

  • Concomitant Therapy: Exercise care in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.

  • Carcinogenicity: Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinoma should be diligently observed and treated.

  • Teratogenicity: Methoxsalen may cause fetal harm when given to a pregnant woman. Women undergoing photopheresis should be advised to avoid becoming pregnant.

  • Cataractogenicity: Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment, any time they are exposed to direct or indirect sunlight and whether they are outdoors or exposed through a window.

  • Safety in children has not been established.

FOR MORE INFORMATION

See product monograph for methoxsalen sterile solution (if used in conjunction with the THERAKOS CELLEX Photopheresis System) and the Operator’s Manual for the CELLEX system at health-products.canada.ca/dpd-bdpp or by calling 1-833-223-4ECP (1-833-223-4327).

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Important Safety Information for THERAKOS® CELLEX® Photopheresis Procedure
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INDICATION

The THERAKOS® CELLEX® Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) and systemic sclerosis (SSc).