The FDA has given breakthrough device designation to the EndoSound Vision System, an add-on ultrasound device designed by EndoSound.
The solution is capable of converting into an endoscopic ultrasound that allows endoscopists to perform advanced procedures such as fine needle biopsy with precision. It does not possess the elevator mechanism found on most linear echo-endoscopes, a component that has drummed up concerns among patients for the risk of infection associated with it.
“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,” said Dr. Shyam Varadarajulu, medical director of the Digestive Health Institute at Orlando Health, in a statement.
The solution is expected to help providers abide by the July 2020 Safety Communication published by the FDA, advising healthcare providers and manufacturers to use duodenoscopes with disposable components due to the risks associated with the elevator mechanisms. Similarly designed ultrasound endoscopes, however, have been overlooked in this regard, according to EndoSound.
Despite eliminating the elevator mechanism, the solution is designed to still retain precision and imaging needed for complex EUS procedures. It is made up of a compact ultrasound beamformer, reusable transducer and disposable mounting kit that attaches to any flexible upper gastrointestinal (GI) video endoscope to convert it into an endoscopic ultrasound (EUS) system.
“There is a clear need for a resolution to the patient safety risk presented by traditional ultrasound endoscopes,” said Dr. Stephen Steinberg, EndoSound founder and president. “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.”
Olympus and Hitachi are currently in the process of developing an endoscopic ultrasound system
through a five year agreement signed between the two earlier this year. They aim to do this by creating compatibility among Olympus’ ultrasound gastrointestinal/bronchial videoscopes and Hitachi’s diagnostic ultrasound systems.
Hitachi also teamed up with HOYA Corporation last year to enhance its development and commercialization efforts
for endoscopic ultrasound systems. The partnership, it says, allows for the company to continue supplying diagnostic ultrasound systems and ultrasound sensor-related parts used in EUS, following the acquisition of its diagnostic imaging-related business by FUJIFILM
Under the Breakthrough Device Designation, EndoSound will be able to provide the FDA with feedback during the premarket phase and prioritized review of its device submission.