GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2
diabetes and obesity, today announced that it has received European CE
mark approval for the EndoBarrier™, a non-surgical therapy to treat type
2 diabetes and obesity. The CE marking (an acronym for the French
"Conformite Europeenne") certifies that a product has met EU
requirements for marketing in Europe. Clinical trials involving more
than 270 patients have demonstrated the significant weight loss and
diabetes improvement achieved with the EndoBarrier Gastrointestinal
Liner.
“This European approval for six months of EndoBarrier therapy to treat
type 2 diabetes and obesity is another key milestone for GI Dynamics as
we continue to prepare to launch the product in Europe”
“Based on the clinical results to date, we believe the EndoBarrier, as
part of a multidisciplinary approach, has the potential to change the
treatment paradigm for type 2 diabetes and weight problems,” stated Jan
Willem Greve, M.D., Ph.D., Gastrointestinal and Bariatric Surgery,
Atrium Medical Center Parkstad Heerlen, Netherlands. “Due to its unique
profile as a non-surgical and non-pharmaceutical treatment option, the
EndoBarrier appears to provide the benefits of gastric bypass surgery
without the complications and risks associated with surgery. Unlike
traditional pharmaceutical approaches, this implantable device removes
the burden of dose regimen compliance from the patient. We look forward
to having access to the EndoBarrier as a new treatment option in our
fight against these epidemics.”