Endolumik’s story started a few years ago as the FDA sounded the alarm over the risks of internal surgical staplers.
In 2019, the federal agency warned healthcare providers that it had received more than 41,000 medical device reports (MDRs) related to surgical staplers and staples for internal use from 2011 to 2018. Those MDRs tallied more than 32,000 malfunctions, at least 9,000 serious injuries and 366 deaths.
Two years later, the FDA increased the risk level associated with the staplers, reclassifying the devices from Class I to Class II and subjecting them to premarket review and special controls.
Bariatric surgeon Dr. Nova Szoka had already been working on a device that could prevent some of those injuries. She envisioned an illuminated gastric calibration tube that would shine near-infrared light through stomach tissue and fat. This camera-visible fluorescence would make it easier to see the tube inside a patient, lessening the risk of a surgeon perforating the stomach or stapling the tube to the stomach during bariatric procedures.
In 2020, Szoka founded Endolumik with Mara McFadden, now CEO of the Morgantown, West Virginia-based device developer. In 2022, they submitted their device to the FDA under the new Safer Technologies Program (STeP) and this year won the agency’s first STeP authorization.
“Safety was always the most important thing,” Szoka said in an interview
Get the full story on our sister site, Medical Design & Outsourcing.