Echo Therapeutics, a medical device company, has reported positive results from its clinical trial of the Symphony CGM wireless continuous glucose monitoring system in surgical patients in hospital critical care units.
Echo Therapeutics will use the study results for the CE Mark technical file submission for marketing approval of the Symphony CGM system in Europe.
The clinical trial, which involved the continuous monitoring of glucose levels in 32 subjects in the critical care units, has been conducted at four investigational sites. The Symphony CGM system has met the primary safety and effectiveness endpoints of the trial.
Echo Therapeutics executive chairman and interim CEO Robert F Doman noted the company is extremely pleased with the positive results of this trial.
"Importantly, this was the largest study of Symphony to date and it was the first time that all of the components of the system were used together in a clinical trial. We believe Symphony demonstrated satisfactory safety, accuracy and reliability during the clinical trial to satisfy CE Mark requirements.
"We believe that there is great clinical need in the hospital for a non-invasive continuous glucose monitoring system, like Symphony, to support glycemic control protocols in hospital critical care units, leading to improved clinical outcomes," Doman added.
The company anticipates submitting the CE Mark technical file for the non-invasive continuous glucose monitoring system in the fourth quarter of 2013.
