J&J's Animas unit gets CE mark for Animas Vibe

Johnson and Johnson's Animas unit last week received CE Mark approval for the first and only continuous glucose monitoring sensor-augmented insulin pump system with the DexCom G4 sensor technology. The system, known as Animas Vibe, displays real-time glucose information and the sensor can be worn for up to seven days. And unlike other CGM-augmented pump systems, Animas Vibe displays glucose trends in color and is waterproof.

CGM-augmented systems like Animas Vibe give patients a more complete glucose picture versus fingersticks alone, according to an Animas statement. It should also provide for better outcomes and compliance compared with sensors worn for three, five or even six days, Animas CMO Dr. Henry Anhalt told FierceMedicalDevices in a telephone interview. With the introduction of the Animas Vibe system, patients who want to enjoy the freedom and flexibility that CGM-augmented pump technology provides now have a choice, he added.

San Diego-based Dexcom develops and markets CGM systems for use at home and in healthcare settings. The partners originally announced a joint development agreement to integrate DexCom's CGM technology into Animas insulin pumps back in January 2008.  They revised the agreement a year later, giving Animas exclusive rights to DexCom CGM technology for integration into its insulin pumps outside the U.S. It also retained the non-exclusive right to develop and market CGM-enabled ambulatory insulin pumps within the U.S. Animas Vibe is the first product offering under this agreement.

Although the product is not yet ready in the U.S., a regulatory submission is being prepared for submission to the FDA this year, Anhalt told FMD. The product initially will be available to people living with diabetes in the U.K., Germany, France, Italy and Sweden. Judging from the reaction of bloggers attending the ATTD and Diabetes UK meetings in London this year, the Animas Vibe should prove a popular choice for diabetics.

- see the Animas release