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Plasma Exchange
A Clear Road to Results for MG and GBS Patients
Overview MG GBS How It Works Safety Resources References

See How Plasma Exchange Can Put Your Patients on a Clear Road to Results

The Spectra Optia system is the first and only therapeutic apheresis system on the European market today with an indication to treat myasthenia gravis (MG) and Guillain-Barré syndrome (GBS) for specific patient populations.* (Chevret et al., 2017) (Cortese et al., 2011) (Sanders et al., 2016) (Elovaara et al., 2008) (Schwartz et al., 2016) Using plasma exchange delivers a rapid clinical response resulting in a fast road to recovery.

*As of December 2016.

Evidence-Based Guidance for Plasma Exchange in MG and GBS

MG

EFNS 20101 Cochrane 20132 ASFA 20163 MGFA consensus 20164
  • Level A for acute exacerbation
  • Level B prethymectomy
  • Moderate–severe (Grade II)
  • Prethymectomy (Grade III)
  • Category I
  • Moderate–severe (Grade 1B)
  • Prethymectomy (Grade 1C)
  • Short-term treatment in myasthenic crisis
  • Prethymectomy
  • Refractory MG
  • Prior to corticosteroids

1Elovaara I, et al. Eur J Neurol. 2008; 15:893-908. 2Raphaël JC, et al. Cochrane Database Syst Rev. 2012(7). 3Schwartz J, et al. J Clin Apher. 2016; 31(3):149-162. 4Sanders DB, et al. Neurology. 2016; 87(4):419-425.

GBS

AAN 20111 ASFA 20162 EFNS 20103

Class I (Level A for severe GBS)

Category I (Grade 1A) and Category III (Grade 2C)

Level A

1Cortese I, et al. Neurology. 2011; 76:294-300. 2Schwartz J, et al. J Clin Apher. 2016; 31(3):149-162. 3Elovaara I, et al. Eur J Neurol. 2008; 15:893-908.

A Clear Road for Your Patients
MG GBS
Safety Information

Contraindications

  • No known contraindications for the system's use, except for those associated with all automated apheresis systems
  • The infusion of certain solutions and replacement fluids may be contraindicated in some patients

Possible patient reactions

  • Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension and allergic reactions

Reactions to transfused blood products can include1

  • Fever, circulatory overload, shock, allergic reactions, alloimmunization, graft-versus-host disease and transmission of infection

Restricted to prescription use only

  • Operators must be familiar with the system's operating instructions
  • Procedures must be performed by qualified medical personnel
  • A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus as long as he or she remains immediately available2

1AABB (ed.), et al., Circular of Information for the Use of Human Blood and Blood Components. 2006, tenth edition, Council of Europe Publishing, Seattle, WA.

2American Society for Apheresis. Guidelines for therapeutic apheresis clinical privileges. J Clin Apher. 2007;22(3):181-182.



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International Content. Approved labeling, indications and instructions may vary by country. Reference the Instructions for Use labeling for a complete listing of indications, warnings and precautions.

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