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 marked 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.
Sanders, DB. International consensus guidance for management of myasthenia gravis. American Academy of Neurology. 2016:350.
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.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.