Capillary Biomedical announced today that it received FDA investigational device exemption (IDE) for its SteadiFlow infusion technology.
Irvine, California-based Capillary Biomedical designed its new SteadiFlow seven-day-wear infusion set technology to significantly extend patient wear time to a week and maintain insulin stability.
The SteadiSet infusion set, powered by the SteadiFlow technology platform, features an integrated inserter designed for an easy, painless, hidden needle, one-handed insertion. In addition, the entire set includes materials to reduce preservative loss for improved insulin stability and reduced aggregate formation.
Capillary Biomedical designed its cannula to filter particles and aggregates before they are delivered to the tissue to ensure that any aggregates that form in the tubing are removed before reaching the tissue, reducing tissue inflammation and potentially improving infusion set reliability.
Garnering FDA IDE will lead to a new pivotal trial for the assessment of SteadiFlow. The non-randomized, prospective, single-arm trial will recruit at least 240 subjects between ages 18 and 80 years old with type 1 diabetes on insulin pump therapy across 15 sites. Each patient will undergo 12 one-week wear periods, according to a news release.
Jaeb Center for Health Research in Tampa, Florida, will serve as the contract research organization (CRO). The study will test Novolog and Humalog insulin.
“With this pivotal trial we are pleased to be taking a significant next step in the evolution of our SteadiFlow infusion set,” Capillary Biomedical CEO Paul Strasma said in the release. “Based on the strength of previous clinical data, we’re optimistic about the results of this forthcoming trial, and we’re excited to play a leadership role in what might be possible with insulin pump technology.”
