SENS: Eversense XL US Pivotal Trial and Insulin Dosing Claim sPMA

Earlier this week, Senseonics announced that the first US study participant has been implanted with the 180-day Eversense XL sensor for the pivotal PROMISE study. Additionally, Senseonics also announced they have submitted PMA supplements for an insulin dosing claim and for the removal of an MRI contraindication for the Eversense 90-day CGM system. Below, FENIX provides additional thoughts on each of these topics. Eversense XL PROMISE study details The aim of this study is to evaluate the efficacy and safety of the Eversense XL CGM in 180 diabetes patients over a 180-day period. Of note, a brief CT.gov search for Senseonics’ PROMISE study did not show any records. Recall, Eversense XL 180-day sensor is commercially available in Europe……

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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