Omaha, NE, June 09, 2023 –(PR.com)– Endolumik, an innovator in minimally-invasive surgical devices, today announced that its fluorescence guided Gastric Calibration Tube has begun commercial sales, starting with the prestigious Nebraska Medicine Bariatrics Center.
Endolumik’s novel surgical tool has been used extensively in clinical trials and recently received 510(k) authorization as the first device ever through the FDA’s Safer TEchnology Program, or STEP. According to the FDA, the STEP program is for devices that are “reasonably expected to significantly improve the safety of currently available treatments.” The NIR fluorescence of the Endolumik device is designed to help surgeons avoid adverse events that can be caused by poor visualization. This procedure with UNMC will mark the first introduction of the device for public use.
Dr. Corrigan McBride, DABOM, FACS, FASMBS, and the Chief of General Surgery, Minimally Invasive Surgery and Bariatrics at UNMC, was eager to be a leader with the device. She is not only the Director of the MBSAQIP accredited Bariatrics Center, but is also a leading researcher in laparoscopic metabolic surgery. “Innovation is one of the core values of Nebraska Medicine and UNMC, so when I saw the Enolumik I was excited about the opportunity to improve patient safety through a new surgical device”
The Endolumik Gastric Calibration Tube uses near infrared (NIR) light to allow surgeons to more clearly visualize surgical tools inside the stomach. The inventor of the device, Dr. Nova Szoka, FACS, FASMBS notes, “It’s our goal to provide surgeons with additional visual cues to help them improve their performance, and standardize surgical outcomes for patients.”
The event also marks an interesting moment of progress in the traditionally male-dominated surgical field. Endolumik is a women-owned, women-led company, founded on the invention of a female surgeon. When Dr. McBride expressed her interest to be one of the first users, both parties thought it seemed a fitting opportunity to have a woman surgeon lead the way for this technological innovation. Dr. David W. Mercer, the Chair of Surgery at UNMC, “Dr. McBride is a leader in Minimally Invasive and Bariatric Surgery. She is always working to improve safety and outcomes for her patients.”
Endolumik is launching the device with a select number of leading hospitals and surgery centers throughout the spring. “We are looking for partners who not only appreciate the technological value of this device for patients, but are excited to be ushering in a new era of higher performing digital surgical tools,” said Endolumik CEO Mara McFadden.