In the wake of warnings from the FDA about safety issues associated with certain ultrasound-equipped endoscopes, EndoSound has secured an agency clearance for a device designed to avoid those issues.
The EndoSound Vision System, or EVS, attaches to any flexible endoscope that has video capabilities and is used in upper gastrointestinal procedures. Comprising an ultrasound beamformer, reusable transducer and disposable mounting kit, once attached, it turns any existing scope into an endoscopic ultrasound system, which can then be used in minimally invasive procedures to collect images of the pancreas, liver, gallbladder and other organs and tissues in and near the upper GI tract.
As it announced the 510(k) FDA clearance Tuesday, Oregon-based EndoSound also said that the “controlled market release” of the EVS system in the U.S. would begin early this year.
The EVS clearance comes just over two years after the FDA first recognized the technology with a breakthrough device designation in the summer of 2021.
At the time, EndoSound highlighted how its system aimed to avoid the patient safety issues associated with other endoscopic ultrasound devices. It cited warnings from the FDA about the reusable “elevator” mechanisms found in many scopes, which help doctors control the positioning of instruments attached to scopes but have been linked to a heightened risk of patient infection.
EndoSound’s approach, meanwhile, forgoes the elevator lever, while still promising doctors plenty of precision and control.
With FDA clearance now secured, EndoSound suggested in this week’s announcement that in addition to improving patient safety, its add-on system may also be more accessible than other, more costly ultrasound-equipped endoscopes. In turn, that accessibility could potentially move more of the GI tract-scanning procedures out of hospitals and into “more efficient” and patient-preferred ambulatory surgery centers and other outpatient clinics, the company said.
The FDA nod—the first for the company—comes not long after EndoSound closed a series A financing round. Though it didn’t disclose the total amount raised, EndoSound did note last spring that the round had been led by GEO Medtech Ventures and that the money would be used to support ongoing R&D efforts as well as preparations for the commercial launch of the EVS device.
In the meantime, the company has also begun work on another endoscopy-upgrading technology. In October, EndoSound announced that it had joined forces with AdaptivEndo to apply its ultrasound technology to AdaptivEndo’s single-use gastroscopes and duodenoscopes to further reduce the safety risks associated with difficult-to-clean reusable scopes.
The companies have already started testing their combined product and shared in last fall’s announcement that they’d completed an animal test of the technology in a simultaneous endoscopic ultrasound and endoscopic retrograde cholangiopancreatography (ERCP) procedure.
The in-vivo porcine test was successful, they reported, marking what they termed “the first-ever simultaneous EUS/ERCP procedure using a singular EUS/ERCP device.”