WVU Medicine surgeon Nova Szoka, MD, developed a new fluorescence-guided medical device to help surgeons better visualize surgical instruments and the surgical area during thoracic and bariatric surgeries.
The device, called Endolumik was tested at WVU Medicine J.W. Ruby Memorial Hospital before receiving approval from the Food and Drug Administration (FDA). It is the first device to be approved through the FDA’s Safer Technology Program, which is designed to expedite the development and approval of medical devices that have the potential to improve patient safety.
During minimally invasive and robotic surgery, Endolumik is advanced under near infrared (NIR) guidance into the lower esophagus and stomach. The NIR light shines through esophageal and gastric tissue, allowing the surgeons to navigate the surgical field and take measurements more precisely.
The device can also be used for application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie, which widens the esophagus, and as a visualization device.
“The idea for the device came to me while performing bariatric surgery,” Dr. Szoka said. “I wanted to find a way to provide surgeons with additional visual cues to succeed in the operating room. Our hope is that the device can help standardize surgical outcomes and ultimately translate to improved patient outcomes.”
Endolumik has grown to envision a new generation of surgical tools that use light and digital surgery techniques to enhance surgeon performance.
“We are thrilled to receive FDA clearance for our gastric calibration tube and to be designated as a Safer Technology Program device,” Mara McFadden, CEO of Endolumik, said. “This is a significant milestone for our company and for the field of minimally invasive surgery. We believe that the Endolumik device has the potential to improve patient safety and outcomes for millions of patients around the world.”
Shalini Reddy, MD, WVU Heart and Vascular Institute thoracic surgeon, was the first to use the device in a thoracic surgery during a recent hiatal hernia repair.
The patient was a woman who had been suffering from severe heartburn and regurgitation for several years. She had tried a variety of medications and lifestyle changes, but her symptoms persisted.
“It was an honor to be the first to use this device for a thoracic procedure,” Dr. Reddy said. “We are always proud to cheer on the accomplishments of our fellow WVU Medicine physicians, and it is particularly special to be a woman who is the first to use a device that was created by a woman.”
The procedure was a success, and the patient was able to go home after two days. She reported immediate relief from her symptoms and has been doing well since.