Un système d'aphérèse recoit le marquage CE pour le traitement du syndrome de Guillain-Barré et de la myasthénie

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Pboulanger
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Un système d'aphérèse recoit le marquage CE pour le traitement du syndrome de Guillain-Barré et de la myasthénie

Message par Pboulanger » 22 avr. 2017 11:52

:hi:
Nous avons reçu une information relative à l'obtention du marquage CE pour une machine utilisé dans le traitement de la MG et du syndrome de Guillain-Barré. Ce marquage est le premier délivré concernant les machines d'aphérèse (ou échange plasmatique aussi appelé plasmaphérèse)

Ci dessous
  • un extrait du message d'information que nous avons reçu
    ...
    Je vous écris pour vous informer que pour la première fois, un système d'aphérèse reçoit le marquage CE pour le traitement du SGB et de la MG

    Le système d'aphérèse Spectra Optia® de Terumo BCT est le premier et unique dispositif sur le marché européen indiqué dans le traitement du syndrome de Guillain-Barré et de la myasthénie grave, grâce à l'utilisation de l'échange de plasma thérapeutique (Communiqué de presse en pièce jointe)

    Les résultats cliniques ont montré un récupération plus rapide via l’élimination rapide des médiateurs de la maladie et des complexes immuns, permettant de soulager les symptômes des patients touchés par le syndrome de Guillain-Barré et la myasthénie. Une procédure unique peut faire diminué rapidement les immunoglobulines, améliorant les prises en charge des patients. Sachant que l’incidence pour le GBS est de 1/100 000 et pour MG est de 2/100 000, nous prévoyons que ces patients bénéficieront de l'accès à la technologie.

    Bien cordialement,

    Dr Mickaël Beraud, PhD
    Medical Science Liaison EMEA
    Medical Affairs and Therapy Awareness Programs
  • ainsi que le communiqué de presse
    Terumo BCT’s Spectra Optia® Apheresis System Is the First and Only Device on the European Market Indicated to Treat Guillain-Barré Syndrome and Myasthenia Gravis Using Therapeutic Plasma Exchange
    4/6/2017

    LAKEWOOD, Colo., USA—April 6, 2017—Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, today announced that the Spectra Optia® Apheresis System with therapeutic plasma exchange (TPE) has received the CE mark with an indication to treat Guillain-Barré syndrome (GBS) and myasthenia gravis (MG). The Spectra Optia system is a centrifugal therapeutic apheresis and cell collections platform and is the first and only device on the European market today approved to treat GBS and MG using TPE. GBS and MG are rare and debilitating orphan neuromuscular diseases. GBS has been associated with the Zika virus infection.

    The expanded use indications were based on reviews of clinical studies supporting the safety and efficacy of TPE for treating GBS and MG. Various studies showed that by rapidly removing circulating disease mediators and immune complexes, TPE resulted in increased speed of recovery for the majority of GBS and MG patients when compared to supportive care. A single TPE procedure can rapidly lower all immunoglobulins (Igs).*

    Spectra Optia TPE, also known as plasmapheresis (or PLEX/PEX), is a procedure during which a patient’s blood is centrifuged to separate blood components, remove the plasma, and then replace the plasma. This procedure is recommended by the European Academies of Neurology and international consensus guidance as a safe and effective first-line therapy for patients with GBS and MG (pre-thymectomy, moderate to severe, crisis and refractory). TPE on the Spectra Optia system can be performed using peripheral vascular access.

    The recently published international consensus guidance for management of myasthenia gravis (Neurology, 2016) stated, “Although clinical trials suggest that intravenous immunoglobulin (IVIg) and PLEX are equally effective in the treatment of impending or manifest myasthenic crisis, expert consensus suggests that PLEX is more effective and works more quickly.”1

    “We are pleased that Spectra Optia TPE is now CE marked with an indication that supports patients with these rare and debilitating neurological disorders, thereby enabling more treatment options,” said Monte Smith, Vice President, Global Therapeutic Systems, Terumo BCT. “We are committed to further innovation in the field of apheresis therapies, with a focus on developing products that deliver life-saving treatment to patients.”

    *Immunoglobulins, also known as antibodies, are produced by white blood (plasma) cells. They act as a critical part of the immune response by specifically recognizing and binding to particular antigens, such as bacteria or viruses, and aiding in their destruction.

    1 Sanders, DB. International consensus guidance for management of myasthenia gravis. Neurology. 2016;87(4):419-425.

    About Terumo BCT
    Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

    Media Contact
    Karen Hackstaff, Terumo BCT
    Director of Strategic Marketing and Communications
    Phone: 720.480.7649

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