THERAKOS™ CELLEX™ System Secures New EU CE Certification

Introduction to the THERAKOS™ CELLEX™ Photopheresis System

THERAKOS™, recognized as the only fully integrated and validated Extracorporeal Photopheresis (ECP) system, has recently achieved the benchmark of receiving the CE certificate under the updated European Union Medical Device Regulation (EU MDR). This accomplishment signifies a step forward in medical device safety and efficacy standards.

Details of the CE Certification

The CE Certification was granted following a comprehensive process that included an extensive quality management system audit, technical reviews, microbiological evaluations, and a detailed clinical assessment. The EU MDR's rigorous framework is designed to foster medical innovation while prioritizing patient safety.

The Certification Process

To attain the CE certification, the THERAKOS team submitted its application, which also featured advancements in design. Notably, these enhancements included:

• The integration of the anticoagulant ACD-A into the existing labelling.
• Significant material changes to eliminate the presence of DEHP, aligning with the latest RoHS standards to safeguard patient health.

Indications for Use

The THERAKOS™ CELLEX™ Photopheresis System is tailored for patients over 18 requiring photopheresis to treat conditions such as:

• Cutaneous T Cell Lymphoma
• Solid Organ Transplant Rejection (specifically for heart and lung patients)

For younger patients, the system is indicated for those over 3 years suffering from:

• Acute and Chronic Graft versus Host Disease.

Statements from Leadership

Christopher Hirt, MD, Vice President Hospital International, expressed optimism regarding the certification: "We are thrilled that THERAKOS has received the CE Certificate which meets the heightened safety and performance standards for medical devices in the EU. This achievement enhances healthcare provider confidence in treating their patients with THERAKOS."

About the THERAKOS™ CELLEX™ System

The THERAKOS CELLEX™ Photopheresis System stands as a beacon of advanced therapeutic technology, conducting ECP through patented methods. This process isolates a small volume of white blood cells, treats them, and reinfuses them back to the patient, thereby harnessing the power of immunomodulation to combat various immune-mediated conditions. More than 300 treatment centres across 30 countries utilize this advanced system.

Understanding Extracorporeal Photopheresis (ECP)

Extracorporeal Photopheresis (ECP) is an innovative therapeutic intervention that has shown significant promise in several immune-related disorders. This therapy is backed by a range of international clinical guidelines endorsing its use for:

• Cutaneous T-cell lymphoma (CTCL)
• Acute and chronic graft-versus-host disease (aGvHD and cGvHD)
• Chronic lung allograft dysfunction
• Conditions following cardiac transplantation.

Safety Information and Precautions

While the THERAKOS™ CELLEX™ Photopheresis System offers promising benefits, it is important to remain aware of the associated risks and contraindications:

Contraindications

• Patients with a history of light sensitivity.
• Individuals unable to tolerate extracorporeal volume loss.
• Those with coagulation disorders or previous splenectomies.

Warnings

• All treatments should take place in environments equipped for medical emergencies.
• Avoid exposing the device to magnetic resonance environments to prevent potential injuries.
• Pay special attention to anticoagulation during Graft versus Host Disease treatments to mitigate thromboembolic event risks.

Methoxsalen and its Role in Treatment

Methoxsalen is often used alongside the THERAKOS™ Photopheresis procedure. However, it's crucial to recognize the contraindications and warnings associated with methoxsalen:

• Not recommended for patients with hypersensitivity to methoxsalen or similar compounds.
• Patients with specific skin cancers, pregnancy, and those who have had lens removal surgery should avoid its use.

About Mallinckrodt

Mallinckrodt is a global leader in specialty pharmaceuticals, committed to developing and distributing products that cater to rare and complex conditions. The company's focus lies in various therapeutic areas including neurology, oncology, and rheumatology, among others. To learn more about Mallinckrodt and its offerings, visit www.mallinckrodt.com.

Frequently Asked Questions

What is the THERAKOS™ CELLEX™ Photopheresis System?

The THERAKOS™ CELLEX™ Photopheresis System is a medical device designed for extracorporeal photopheresis, a therapy for immune-mediated diseases.

Who can use the THERAKOS™ CELLEX™ System?

It is suitable for patients over 18 years with specific diseases like Cutaneous T Cell Lymphoma and for younger patients suffering from Graft versus Host Disease.

What are the key updates in the CE certification process?

The updated certification process involved enhanced design features and stringent regulatory compliance measures to enhance safety and performance.

What diseases are treated with ECP therapy?

ECP therapy is recommended for conditions such as CTCL, graft-versus-host disease, and chronic lung allograft dysfunction.

How should Methoxsalen be administered?

Methoxsalen must be used cautiously and is contraindicated for specific patient groups; awareness of its risks is essential.

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