The final approval has been received for the V-Go Disposable Insulin Delivery Device. This latest step means that the new device, which delivers insulin to type 2 diabetics, is now approved for sale to the public.
Manufactured by the U.S. medical technology company Valeritas, the device received the coveted CE mark of approval which allows it to be sold in the European Economic Area (EEA). It also received the ISO 13485: 2003 Quality Management System Certification.
The V-Go system offers two different services. First, it offers a basal rate of insulin on a continuous, preset basis. It also provides bolus doses around mealtimes on an on-demand basis. Until now, the only treatment option that patients had was to give themselves multiple injections of insulin throughout the day.
“These are important corporate milestones for Valeritas as we evaluate the commercialization of the V-Go outside of the United States,” said Kristine Peterson, chief executive at Valeritas.
Peterson added: “The CE Mark, coupled with our FDA 510(k) clearances in December 2010 and February 2011, affords us the opportunity to provide an innovative therapeutic option to the millions of adults who require insulin to treat their diabetes.”
There are approximately 37.5 million diabetic adults currently living in the EEA region. Approximately 5 million of those use insulin as part of their therapeutic treatment.
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