Next-Generation OmniPod(R) Insulin Pump Cleared by FDA; New Tubeless Insulin Pump Is More Than One-Third Smaller and One-Quarter Lighter
DATELINE: BEDFORD, MA; Dec 14, 2012
Insulet Corporation (NASDAQ: PODD), 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(R) 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 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." "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.
Wow...Cool picture posted Erik showing the two sizes! I'm hoping this new smaller podd will stay on much better seeing that it uses the same size adhesive but by being smaller and less wieght it should stay put much better...!!!
@ Megan Ritter;Y es, after using it now for several weeks I think the diffrences you mentioned are the most important. One drawback is that you have to identify yourself on the PDM.
I wouldn't call that a drawback. I put my name/address/etc on my PDM in the "My Info" part of the current PDM. I think it's great now they make it more specific.
Thanks for the link. That's a lot more information than I think we had before. I love the pink canula insert marker. And the vibrate is cool too, except I do wish it would vibrate at the end of a bolus instead of beep. That can be somewhat of an annoyance in some situtations. Beeping in a quiet room with others, and having to explain why you beeped...
Really excited it's finally been approved. I just got my PDM replaced because it kept having problems communicating (had to put it right against the pod)... hopefully that won't impact getting switched over when the new ones are shipped.
Just posted this on another thread but figured it's relevant here too, so:
Been using the new Omnipods for a few weeks now and very impressed. Only time will tell for reliability but no issues with filling/priming/starting so far.
The new pods really are noticeably smaller and are definitely easier to get a wetsuit over - the adhesive seems to hold up better after prolonged immersion too. Reduced mass of the pods was also noticeable for the first couple of days, particularly when running and cycling on rough terrain. Coloured canula is also a nice touch and makes it far easier to check for problems.
Only downside so far is that they're way harder to get into; probably not an issue for most but I like to break 'em apart for recycling - needle & canula in sharps bin of course.
As for the PDM, physically there's no change other than the colour; it's now black. As for firmware, the only changes I've spotted so far are:
1. ID confirmation prompt at waking: when waking from sleep the PDM asks you to confirm that you're you - you have to give the PDM an ID at setup to facilitate this. I guess this is to avoid inadvertent swapping of PDMs if there's a gaggle of podders around.
2. Additional extended bolus options; think I spotted something about this in the manual but may be wrong. Will check again.
As for other features/changes, the blister packs are slimmer thus making it easier to carry spares. Also, filling needles are MUCH shorter to accommodate the thinner form of the pods.
That's all I can think of for now but I'm happy to answer question from anyone that's interested.
