Colorado-based medical device maker Encision (PINK:ECIA) won FDA clearance for the latest in its active electrode monitoring (AEM) technology, designed to maker monopolar laparoscopy safer for patients.
Encision’s EndoShield is a plug-and-play add-on for common surgical generators, giving surgeons alternative energy choices for use in monopolar laparoscopic procedures.
Devices that use monopolar energy must shield patients against stray currents that can cause burns to vital tissue. More than 4,000 patients die each in the U.S. due to complications associated with stray monopolar energy, according to Encision.
The company leverages its AEM technologies to eliminate stray energy burns, not only a risk to patient’s live but a potentially significant drain on healthcare budgets.
The new EndoShield is an all-in-one system that combines a "disposable smart cord" and an AEM monitor that helps surgeons recognize when there may be stray energy during a procedure. Most stray currents occur outside of a clinician’s field of view, and an estimated 69% go unnoticed, Encision said.
"We are pleased to have achieved this milestone towards the introduction of our EndoShield burn protection system," president & CEO Greg Trudel said in prepared remarks. "Feedback from the marketplace has been very positive. Our customers appreciate the advancement of the technology, the increase in ease of use, and the freedom from the constraint of capital expense. We look forward to launching our new device and to increasing the proliferation of advanced AEM monopolar energy and patient safety."