FDA approves Animas Vibe insulin pump system for pediatric patients
The FDA recently expanded approval of the Animas Vibe Insulin Pump and Continuous Glucose Monitoring System for the treatment of diabetes to include children and adolescents aged 2 to 17 years, according to a press release from Animas.
This approval makes this the only system available in the United States for pediatric patients as young as 2 years of age that includes the Dexcom G4 PLATINUM CGM technology.
“CGM-enabled systems, like the Animas Vibe System, provide patients with a more complete glucose picture, which is acutely important for children since they might not always be aware of the symptoms associated with high or low blood sugars,” Brian Levy, MD, Chief Medical Officer of Animas, said in the release. “The approval of the pediatric indication for Animas Vibe System enables parents and caregivers to both deliver insulin precisely and monitor glucose trends accurately in children as young as age 2 with one integrated device.”
System features include fine-tuned insulin delivery, waterproof durability, customizable alerts, CGM in full color, an accurate and long-wear sensor and one of the smallest introducer needles.
“It’s been our goal as a company to not only develop the best treatment solutions available, but also ensure that every member of the diabetes community, including children, may access these tools,” John Wilson, worldwide vice president of insulin delivery at Animas, said in the release. “We’re thrilled that the FDA approval of this new indication for the Animas Vibe System for the first time now allows children as young as age two access to a CGM-enabled pump.”