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Endolumik’s illuminated device takes a big step for safety

March 21, 2023 By Jim Hammerand

The Endolumik Gastric Calibration Tube is a clear tube with LEDs along the length.
The Endolumik Gastric Calibration Tube emits near-infrared light for enhanced visibility during bariatric procedures.

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.

Filed Under: Regulatory, Tubing Components Tagged With: Endolumik

About Jim Hammerand

Jim Hammerand is the managing editor of Medical Design & Outsourcing. He has more than 15 years of professional journalism experience spanning newspapers, magazines, websites and broadcast news. For nearly a decade, he reported and edited business news for American City Business Journals as a reporter and digital editor at the Minneapolis/St. Paul Business Journal and then managing editor of the Puget Sound Business Journal in Seattle. He holds a bachelor’s degree in journalism from the University of Minnesota. He is based near Seattle in Edmonds, Washington, where he and his family live. Connect with him on LinkedIn or by email at jimhammerand@wtwhmedia.com.

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