Thursday April 6, 2017 0 comments
LAKEWOOD -- 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, the company said.
GBS and MG are rare and debilitating orphan neuromuscular diseases, and GBS has been associated with the recent Zika virus infection.
Terumo BCT said 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, the company said.
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.
"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, Terumo’s VP of Global Therapeutic Systems.
"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.”