The Food and Drug Administration on Dec. 13 cleared Boston Scientific’s single-use duodenoscope, the Exalt Model D, for endoscopic retrograde cholangiopancreatography.
Boston Scientific
The Exalt Model D
It’s the first disposable duodenoscope to hit the market in the wake of the agency’s August call for manufacturers and health care facilities to move to partially or fully disposable duodenoscopes. The goal is to eliminate the risk of spreading infections between patients from incomplete sterilization of traditional, multi-use scopes. The FDA also recently approved a Pentax duodenoscope with a disposable elevator, the most difficult part to clean.
The agency reported in April that 5.4% of samples from multi-use scopes test postive for Escherichia coli, Pseudomonas aeruginosa, or other “high-concern” organisms.
Boston Scientific spokesperson Kate Haranis said the Exalt Model D will be available in the first quarter of 2020, but the company is still working out how much it will charge.
Cost effectiveness will depend largely on the degree to which the price of the device is offset by the infections it prevents. It might prove particularly attractive to high-volume centers with higher than usual infection rates. It might also be of interest to smaller practices where the price of a multi-use scope doesn’t make sense for only a few procedures a year, said Gyanprakash Ketwaroo, MD, an interventional endoscopist and assistant professor of gastroenterology at Baylor University, Houston.
“The feel is a little different,” said Dr. Ketwaroo, who’s tried the new device, but “it’s pretty functional and probably okay to use in almost all endoscopic procedures that require ERCP.”
In a study funded by Boston Scientific, endoscopists reported a median overall satisfaction score of 9 out of 10 with the new scope (Clin Gastroenterol Hepatol. 2019 Nov 6. doi: 10.1016/j.cgh.2019.10.052).
As for using it at Baylor, Dr. Ketwaroo said, “we’re not sure yet; we are still evaluating it” and want to see if any problems emerge once it’s on the market. It’s also not clear if infection risks would be lower than with the disposable elevator model from Pentax, he added.
The Exalt Model D was granted breakthrough status by the FDA, and the agency worked closely with Boston Scientific to bring it to market.
“The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the United States each year. The FDA continues to encourage innovative ways to improve the safety and effectiveness of these devices,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
Dr. Ketwaroo had no relevant financial disclosures.