Senseonics Holdings, Inc. Announces First Study Participant Implanted in the U.S. as Part of the PROMISE 180-Day Sensor Clinical Study and the Submission of Key PMA Supplements to the FDA to Advance Current 90-Day Product
January 04, 2019 at 03:15 am IST
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Senseonics Holdings, Inc. announced that the extended life Eversense® XL sensor that lasts up to 180 days has been implanted in the first U.S. study participant as part of the clinical trial for pre-market application submission to the Food and Drug Administration. The PROMISE Clinical Study is intended to evaluate the safety and efficacy of the Eversense CGM system in people with diabetes over a 180-day period. Approximately 180 study participants at up to 15 locations across the United States are planned to enroll in the study. The Eversense XL sensor previously received the CE Mark and is currently marketed to patients across the European Union. Senseonics also announced that the company has completed its submission of PMA supplements to the FDA to secure an insulin dosing claim and to remove the contraindication related to the Magnetic Resonance Imaging (MRI) exposure on the 90-day system which is currently available in the United States.
Senseonics Holdings, Inc. is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the diabetes community. Its glucose monitoring (CGM) systems, Eversense, Eversense XL, and Eversense E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every five minutes to a mobile app on the user's smartphone. Eversense consists of three primary components: a small sensor inserted subcutaneously under the skin by a healthcare provider; an external removable smart transmitter that receives, assesses and relays data from the sensor and provides vibratory alerts; and a mobile app that receives data from the transmitter and provides real-time glucose readings, alerts and other data the person's mobile device. Its CGM system continually and accurately measures a person's glucose levels for up to six months.
Senseonics Holdings, Inc. Announces First Study Participant Implanted in the U.S. as Part of the PROMISE 180-Day Sensor Clinical Study and the Submission of Key PMA Supplements to the FDA to Advance Current 90-Day Product