Valeritas Receives FDA 510(k) Clearance for the V-Goâ„¢ Disposable Insulin Delivery Device
BRIDGEWATER, N.J., Dec. 8, 2010 /PRNewswire/ -- Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced today that the US Food and Drug Administration has cleared the company's V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. V-Go devices will be available in a preset basal rate to deliver 20, 30 or 40 Units of insulin in one 24-hour period (0.83 U/hr, 1.25U/hr or 1.67U/hr respectively) and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period).
"The V-Go Disposable Insulin Delivery Device is the first fully disposable, non-electronic basal-bolus device that is specifically designed with the Type 2 population in mind," said Valeritas CEO Kristine Peterson. "We believe that the simple user features of the V-Go will allow more patients with diabetes to adhere to their insulin regimen, which ultimately may lead to better control."
"The addition of the V-Go Disposable Insulin Delivery Device as an insulin delivery option for the Type 2 diabetic population is a great step forward in patient care. The more options these patients have the better," said Nancy Bohannon, MD, an endocrinologist from San Francisco, CA. "The V-Go provides a simple way to deliver basal-bolus insulin therapy, which I believe will increase patient compliance and improve glucose control in a very cost-effective manner compared to more traditional insulin delivery devices."
Valeritas plans to commercialize the V-Go in the United States in 2011.
About the V-Go Disposable Insulin Delivery Device
The V-Go is the first simple, fully disposable device for the delivery of basal-bolus insulin therapy for adults with diabetes. The V-Go provides a continuous preset basal rate of insul