Ore.-based Endosound, Inc. announces that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. FDA. The EndoSound Vision System is an add-on device that consists of a compact ultrasound beam-former, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastrointestinal video endoscope to convert it into an endoscopic ultrasound (EUS) system.
Its distal attachment allows the endoscopist to perform advanced procedures, such as fine needle biopsy, with precision, but without the controversial elevator mechanism found on most other linear echo-endoscopes.
In recent years, multi-use endoscopes that feature an elevator mechanism have faced scrutiny due to their association with patient infection risk. In a July 2020 Safety Communication published by the FDA, it was stated that “FDA recommends healthcare facilities and manufacturers begin transitioning to duodenoscopes with disposable components” to address the challenges presented by the elevator mechanisms on these endoscopes.
Major device manufacturers have consequently responded with new disposable duodenoscope models, but the similarly designed ultrasound endoscopes have been overlooked. The EndoSound Vision System addresses this oversight by eliminating the need for the elevator mechanism while still maintaining the precision and imaging that is necessary for complex EUS procedures.
“The EndoSound Vision System removes significant patient safety concerns that have been connected with the elevator mechanism over the last several years,” says Shyam S. Varadarajulu, MD, medical director of the Digestive Health Institute at Orlando Health. “In addition to reducing risk, the system features a disruptive price point that gives it the potential to dramatically expand the availability of this critical modality in the United States and around the world.”
“The Breakthrough Device Designation is evidence of the transformative potential the EndoSound Vision System presents,” adds Stephen Steinberg, MD, EndoSound founder and president. “There is a clear need for a resolution to the patient safety risk presented by traditional ultrasound endoscopes. Also, for many healthcare facilities, the high cost of conventional systems creates a barrier to entry into the use of endoscopic ultrasound. With Breakthrough Device Designation, we are on an accelerated pathway to eliminating these obstacles.”
The FDA Breakthrough Device Designation expedites the development and evaluation of novel devices that offer the potential to enhance patient outcomes through more effective treatment or improved diagnosis of life-threatening conditions. Under the program, the FDA will provide EndoSound with the opportunity to provide its feedback during the pre-market phase and prioritized review of the device submission.