A next-generation endoscope technology aims to radically improve minimally invasive flexible endoscopic surgery by harnessing the power of intelligently micro-machined smart materials to create highly dexterous manipulators at millimeter and sub-millimeter scales, thereby enhancing therapeutic outcomes.

The disruptive platform technology from EndoTheia Inc. (Nashville, TN, USA), based on extremely thin-walled, laser-machined metallic tubes, enables the creation of highly flexible, steerable devices that can pass through standard endoscopes, while also carrying within themselves interventional tools. The steerability that these devices provide to endoscope-delivered tools opens the door for new diagnostic and therapeutic applications of flexible endoscopy. The technology can be used across a vast array of clinical specialties, including urology, gastroenterology, neurology, and otology.

EndoTheia’s proprietary technology exploits pre-programmed mechanical properties in concentric super-elastic tubes to enable tool steerability at the tips of flexible endoscopes without any modification to the endoscope itself. This eliminates parasitic bending along the instrument length like with tendon-actuated systems. By doing away with pullwires and discrete linkages, EndoTheia can create steerable tools with thinner walls and smaller diameters than ever before. It is this capability that allows the company to create dexterous instruments all the way down to 2F in diameter, with an open lumen allowing for the passage of adjunct tools, fluid flow, or suction/irrigation, adding value to the most demanding endoscopic applications. Coupling EndoTheia’s steerable tips with proprietary insertion shaft technology enables distal dexterity at the most demanding of curvatures and deflection angles, with high torsional trackability, axial stiffness, and bidirectional steerability.

EndoTheia has gained priority status from the FDA by receiving a Breakthrough Device designation from the agency for its next-generation endoscope technology. EndoTheia has demonstrated feasibility in animal, cadaver, and tissue model studies in surgeries for biliary disease, ureteroscopy kidney stone removal, endoscopic submucosal dissection (ESD), endoscopic neurosurgery, sinus surgery, and middle ear surgery. EndoTheia’s technology can provide dexterity in any procedures where tools are delivered through flexible endoscopes, including urology, neurology, interventional pulmonology, gastroenterology, colorectal, orthopedics, otolaryngology (ENT), and other sub-specialties.

“EndoTheia’s technology is currently the only viable option to add dexterity to flexible endoscopy, without re-engineering the endoscope itself,” said Robert J. Webster, III, PhD, Co-Founder and President of EndoTheia. “This empowers surgeons to provide much more accurate and precise therapeutic interventions in a wide range of clinical specialties.”

“We are excited that the FDA has recognized the huge potential of EndoTheia’s technology through Breakthrough Device designation,” added S. Duke Herrell, III, MD, FACS, Co-Founder and Chief Medical Officer of EndoTheia. “The FDA has affirmed our view that there is nothing else out there capable of doing what we do for flexible endoscopy, and that our technology represents a breakthrough treatment option for patients who currently face irreversibly debilitating disease.” 

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