“Next-Generation” OmniPod® Insulin Pump Cleared by FDA

In short

Insulin pump technologist Insulet Corporation, has gained 510(k) clearance to market what it’s calling the “next-generation” OmniPod® Insulin Management System. The new 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.

Background

The OmniPod® Insulin Management System is the world’s first tubeless insulin pump, offering people living with insulin-requiring diabetes all the benefits of insulin pump therapy, with freedom and ease.

The tubing-free OmniPod insulin pump has just two easy-to-use parts: the discreet, waterproof Pod, which automatically inserts and can be worn on many parts of the body to hold and deliver insulin; and the Personal Diabetes Manager (PDM), a hand-held device that wirelessly programs the Pod, calculates suggested doses and has a built-in blood glucose meter.

Existing customers are encouraged to refer to the dedicated Omnipod website in order to keep informed about the exact timing and availability of the new System, including details on how current users will be converted. Additionally, users will receive direct notification from the Company when the conversion process is commencing.

Physician comments

“When technology can make diabetes management easier for my patients, they have better clinical outcomes,” said Steve Edelman, MD, Clinical Professor of Medicine at the University 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.”

 Company comments

“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.”

“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.”

Source: Insulet Corporation, Marketwire