http://www.insulet.com/news/item/147
The OmniPodTM Insulin Management System, designed to simplify intensive
insulin therapy, will be available later this year
BEDFORD, MA -- February 1, 2005 -- Insulet Corporation announced today
that its first commercial product, the OmniPod(tm) Insulin Management
System, has received 510(k) clearance from the U.S. Food and Drug
Administration. This innovative two-part system, combining the proven
healthcare benefits of continuous subcutaneous insulin delivery and
blood glucose monitoring technology, eliminates the need for daily
insulin injections, does not require the patient to be tethered to a
conventional insulin pump via tubing, and makes intensive insulin
therapy easier than ever. The System will be available by prescription
later this year.
A Safe, Convenient, and Discreet Solution
The OmniPod Insulin Management System builds upon the safety and
reliability of today's conventional insulin pumps, while incorporating
new technology and features that offer unprecedented performance,
convenience, and ease of use. Similar to currently available insulin
pumps, the System features fully programmable continuous subcutaneous
insulin delivery with multiple basal rates and bolus options, suggested
bolus calculations, safety checks, and alarm features. It also
incorporates blood glucose monitoring technology.
However, unlike current insulin pumps, the OmniPod Insulin Management
System features a fully-integrated design with only two, easy to use
components: the OmniPod and the Personal Diabetes Manager (PDM). The
OmniPod is a small, lightweight device that combines an integrated
infusion set, automatic inserter, and insulin reservoir. The pod is worn
discreetly and comfortably on the skin beneath the clothing, and
delivers insulin according to pre-programmed instructions from the
wireless, handheld PDM. Once the OmniPod is programmed, the PDM is used
to check blood glucose levels, give bolus dosages, and adjust basal
rates. Since there is no tubing connecting the OmniPod and the PDM, the
PDM can be carried separately in a backpack, briefcase, or purse when
the patient is not actively using it to manage their insulin or check
their glucose. Each OmniPod is designed to be worn for up to three days,
and then is removed and replaced with a new pod.
Other features of the OmniPod Insulin Management System include a
user-friendly, intuitive user interface, the ability to store and review
insulin delivery, carbohydrate, and blood glucose results, and a
built-in food reference library.
"Our goal has always been to improve quality of life for people with
diabetes by simplifying management and addressing the concerns of
individuals who live with diabetes every day," said Duane DeSisto,
President and CEO of Insulet Corporation. "The new OmniPod Insulin
Management System offers a safe, convenient, and discreet solution for
patients that want to take advantage of the many benefits of intensive
insulin therapy without the hassle of injections and the complexity of
conventional insulin pumps."
About Insulet Corporation
Founded in August 2000, Insulet Corporation is a privately-held,
innovative diabetes management company dedicated to designing and
developing products that provide superior treatment options and lifelong
health benefits for people with diabetes. Insulet Corporation employees
have extensive knowledge and experience in the diabetes and medical
device industries. The company is located in Bedford, MA.
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