Insulet Corporation, the leader in tubeless insulin pump technology, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next-generation OmniPod® Insulin Management System. The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features. In addition to the smaller, lighter Pod, the new OmniPod System includes an updated Personal Diabetes Manager (PDM) that also features a series of enhancements.
“The OmniPod revolutionized insulin delivery with its tubeless and wireless design when it was introduced in 2005 and today, the next-generation OmniPod raises the bar for insulin pump therapy again,” said Duane DeSisto, President and Chief Executive Officer of Insulet. “We are thrilled to have received FDA approval and it is my hope that our new Omnipod insulin pump will continue to make living with diabetes easier for our customers across the United States.”
“When technology can make diabetes management easier for my patients, they have better clinical outcomes,” said Steve Edelman, MD, Clinical Professor of Medicine at theUniversity of California at San Diego and founder of Taking Control of Your Diabetes (TCOYD), a not-for-profit organization with the goal of teaching and motivating patients in diabetes self-care. “As an OmniPod wearer myself, I love its ease of use and no tubing! Now with its smaller and sleeker design, it will make it even easier for more people to take control of their diabetes.”
“Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production,” said Mr. DeSisto. “We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013. Like the System itself, converting our current OmniPod users to the new system has been designed to be extremely easy as to ensure a seamless transition.”
Customers are encouraged to keep informed via http://www.MyOmniPod.com/NewOmniPod where the Company will publish its latest information about the exact timing and availability of the new OmniPod System, including details on how current users will be converted. Additionally, current users will receive direct notification from the Company when the conversion process is commencing.
While performing its launch preparation initiatives, Insulet continues to collaborate closely with healthcare providers and patients so they can enjoy the many benefits of the current OmniPod today.