Medtronic Inc. (NYSE:MDT) began enrollment into a new continuous glucose monitor trial and revealed positive results from a retrospective trial of its Aquamantys surgical seal system in adolescent spinal surgeries.
The Minneapolis-based med-tech goliath enrolled the first two patients into a new trial of the Enlite continuous glucose monitor this week at centers in Seattle, Wash., and San Diego, Calif.
The Enlite system is the company’s latest innovation in continuous glucose monitoring for people with diabetes, designed to provide improved blood-sugar detection and comfort over traditional fingerstick testing.
"The Enlite sensor is designed to provide improved hypoglycemia detection and better overall system accuracy," Medtronic diabetes business chief medial officer and VP of global clinical affairs Dr. Francine Kaufman said in prepared remarks. "The study will demonstrate whether these improvements, combined with our system’s ability to predict when hypoglycemic events will occur through predictive alerts, can help people with diabetes achieve better glucose control."
The 6-day trial is a multi-center, randomized, prospective study sponsored solely by Medtronic, according to the press release.
The Enlite sensor is also featured in Medtronic’s Aspire study, a pivotal clinical trial of a so-called “artificial pancreas” for Type I diabetics.
The FDA granted Medtronic an investigational device exemption for the second phase of the Automation to Simulate Pancreatic Insulin Response trial, which will involve in-home study of its subjects (the trial’s first leg involved in-patient treatment).
It’s designed to test the low glucose suspend feature in Medtronic’s MiniMed Paradigm insulin pump and its Enlite continuous glucose sensor.
Also released this week, Medtronic touted results of a retrospective study of its Aquamantys bipolar sealer in use during scoliosis corrective surgery in adolescents.
The Aquamantys system uses proprietary transcollation technology, using radiofrequency energy and saline to hemostatically seal soft tissue and bone during surgery. The device helped surgeons significantly limit blood loss by nearly 60 percent, reducing the need for blood transfusions, according to the study.
"The holy grail of spinal fusion in children has always been bloodless surgery," study co-author Dr.. Keith Mankin said in a press release. "While we are not there yet, with the Aquamantys System and a blood conservation program, I feel that we are getting closer to this goal."
