FDA Grants Breakthrough Device Designation for Innovative EndoSound Vision Ultrasound System
PORTLAND—August 31, 2021—Endosound, Inc., an Oregon-based medical device innovator developing technologies that enhance access, reduce cost, and increase the safety of endoscopic ultrasound procedures, announced today that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
The EndoSound Vision System is an add-on device that consists of a compact ultrasound beamformer, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastrointestinal (GI) video endoscope to convert it into an endoscopic ultrasound (EUS) system. Its unique distal attachment allows the endoscopist to perform advanced procedures, such as fine needle biopsy, with precision, but without the controversial elevator mechanism found on all 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 health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components”1 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 innovative 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,” stated Dr. 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,” stated Dr. 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.
Endosound, Inc., is a privately held company based in Portland, Oregon that is dedicated to expanding access to endoscopic ultrasound technology around the world. The company comprises an experienced team of scientists, engineers, clinicians, and business professionals with track records of commercializing new medical devices.
1. U.S. Food and Drug Administration. (2020). The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication [online]. Available at: https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication [Accessed 13 Jul. 2021].