GlySure said today that it won CE Mark approval in the European Union for its continuous intravascular glucose monitoring system.
The CIGMS device was cleared to monitor blood glucose among adult cardiac surgery patients in intensive care units, Abingdon, England-based GlySure said.
In a clinical trial, the device met the primary safety and efficacy endpoints and demonstrated a consistently high level of accuracy compared to intermittent glucose analyzers, the company said.
“For over a decade, the clinical community has been seeking a way to tightly control glucose levels in critically ill patients for both improved outcomes and reduced costs. GlySure’s technology enables them to do this safely with accuracy, reliability and efficiency to support the implementation of improved glycaemic control protocols,” principal investigator Dr. Krishna Prasad of Hyderabad, India’s Care Hospitals, Nampally, said in a press release.
GlySure said it is running a UK-based multicentre trial in hopes of winning indications for the device across all adult intensive care patients.
“We are pleased to bring to market the 1st practical solution to address this significant unmet medical need. Our 1st customers will lead the way in how glucose management is best practiced, enabling improved patient outcomes and reduced healthcare costs. Continuous glucose monitoring in critical care has been a vexing medical challenge. GlySure’s game changing technology and elegant CIGMS solution will be the first in this market to deliver clinical value to patients and savings to healthcare providers,” COO Roger Moody said in prepared remarks.
GlySure said it intends to seek FDA clearance for the device, and is currently finalizing the clinical trial design to support the submission.