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November 25, 2024 | Tom Ballard

EndoTheia completes first-in-human clinical trial for the FlexStone™ Basket for kidney stones

The technology was developed by EndoTheia’s founders at Vanderbilt University and the University of Tennessee, Knoxville.

If you’ve ever had a kidney stone, you know how painful it can be.

EndoTheia Inc., a Nashville-based leader in innovative surgical technology, has announced the successful completion of the first-in-human clinical trial for the FlexStone™ Basket, the first-ever independently steerable kidney stone basket. This groundbreaking device enables unmatched precision and control in kidney stone removal, providing a significant advancement in urological care.

The clinical trial was conducted at Vanderbilt University Medical Center by Nicholas Kavoussi, M.D., and Ryan Hsi, M.D., who served as co-lead investigators.

The FlexStone Basket empowers surgeons to directly steer the device, enabling more effective maneuvering around anatomical structures to reach stones in difficult-to-access locations within the kidney. This capability addresses longstanding limitations of conventional kidney stone retrieval devices, potentially improving patient outcomes and reducing procedural complexity.

“The FlexStone Basket offers unprecedented flexibility and control, enabling us to access and retrieve stones in challenging locations that would otherwise be difficult to reach,” said Dr. Kvoussi, co-lead investigator. “It’s a game-changer that brings a new level of precision to kidney stone removal procedures.”

Dr. Hsi, the other co-lead investigator in the clinical trial, emphasized the device’s impact on patient care, stating, “This device enables us to minimize invasiveness while maximizing our efficiency and effectiveness in removing stones. FlexStone has the potential to transform how we approach complex kidney stone cases, and we’re thrilled to be part of this milestone in urological innovation.”

Looking ahead, EndoTheia has entered into a strategic partnership with Nissha Medical Technologies to support the commercial scale-up of the FlexStone Basket and to advance innovations in minimally invasive endoscopy. This collaboration will enable EndoTheia to accelerate its innovation pipeline, bringing transformative solutions to market more quickly and enhancing surgical capabilities for physicians and patients globally.

The technology was developed by EndoTheia’s founders at Vanderbilt University and the University of Tennessee, Knoxville, with funding from the National Institutes of Health and Launch Tennessee.



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