Image courtesy of Business Wire

FDA clears GI Scientific’s ScopeSeal single-use disposable endoscopic shield

GI Scientific, LLC, a developer of transformative innovations for gastrointestinal disease, announced that the U.S. Food and Drug Administration (FDA) cleared its ScopeSeal Duodenoscope Protective Device, an endoscopic shield for protecting the distal end of a duodenoscope from contamination during ERCP procedures. ScopeSeal  is a single-use disposable infection control device that preserves duodenoscope optics and other key functionality while sealing the infection prone distal end of the Olympus duodenoscope used in ERCP procedures. ScopeSeal is the only device cleared for human use by the FDA that seals the elevator area of the scope and significantly reduces duodenoscope distal end contamination during use.

More than 700,000 U.S. ERCP procedures, and nearly 2 million global ERCP procedures are performed annually as an important less invasive treatment alternative to invasive surgery for assessing and treating critical liver, pancreas, and gallbladder conditions. These highly beneficial, less invasive procedures rely on reusable duodenoscopes as the central enabling technology for these treatments; however, hard-to-clean recessed areas at the distal end of the scope, especially the recessed elevator area, have been linked to failures to remove biomatter contamination from the scope through scope disinfection and reprocessing efforts, resulting in patient-to-patient cross contamination and multiple drug-resistant infections. Significant infection outbreaks and multiple deaths have been reported from drug-resistant infections linked to contaminated duodenoscopes.

ScopeSeal easily and securely attaches to the distal end of a reusable duodenoscope to two-way protection of the scope–: an “outside in” barrier ndesigned to significantly reduce biomatter soiling of the distal end of the scope during use and “inside out” protection, which seals the elevator area of the scope and provides a sealed passageway allowing instruments to be passed through the duodenoscope into the patient’s GI tract without contacting the elevator area of the scope, according to the manufacturer.

ScopeSeal is cleared for use on the Olympus TJF-Q180V duodenoscope, the duodenoscope used in approximately 85% of U.S. ERCP procedures, and is compatible with instruments used in ERCP up to 10.7 Fr in diameter. ScopeSeal is not a replacement for careful adherence to the important and valuable duodenoscope reprocessing steps and related scope maintenance requirements specified by the reusable duodenoscope manufacturer.

The ScopeSeal infection control technology is a platform applicable to other scopes and indications, including duodenoscopes with non-sealing disposable caps, which the company is evaluating with respect to pursuing additional, future regulatory clearances.