News | Endoscopes | December 23, 2019

FDA Clears First Fully Disposable Duodenoscope

This eliminates the potential for infections caused by ineffective reprocessing  

The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems

December 23, 2019 — The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

“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 U.S. each year.  Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients, and the FDA continues to encourage innovative ways to improve the safety and effectiveness of these devices.”

Duodenoscopes are used as a less invasive method than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. The flexible, lighted duodenoscope is threaded through the patient’s mouth and stomach to access the top of the small intestine. Traditionally, these devices have been intended for use on multiple patients, which has required these devices to be cleaned and disinfected (i.e. reprocessed) in between uses to reduce the potential for infection between patients. However, duodenoscopes are complex medical devices with many small working parts that can be difficult to clean. The device can trap contaminated tissue or fluid in its crevices and, if not thoroughly cleaned and disinfected, it can transmit infection-causing bacteria between patients. The EXALT Model D Single-Use Duodenoscope is intended for use on a single patient, therefore removing the potential risks associated with ineffective reprocessing. 

The FDA previously issued communications to health care facilities regarding risks associated with ineffective reprocessing of duodenoscopes that are used on multiple patients. In August, the FDA released a safety communication recommending that duodenoscope manufacturers and health care facilities transition to duodenoscopes with partially- or fully- disposable designs, which can simplify or eliminate the need for reprocessing of certain components, therefore reducing or eliminating between-patient duodenoscope contamination. The FDA previously cleared duodenoscopes with disposable endcap and elevator components. Today’s clearance is the first fully disposable duodenoscope device.

Risks of using the EXALT Model D Single-Use Duodenoscope include the potential for injuries, such as, but not limited to, burns, electric shock, perforation, infection and bleeding.

The EXALT Model D Single-Use Duodenoscope was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development to expedite evidence generation and the agency’s review of the product. To qualify for such designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.

The EXALT Model D Single-Use Duodenoscope was reviewed through the premarket clearance (510(k)) pathway. A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate how a new device is substantially equivalent in intended use and technological characteristics to a legally marketed predicate device. As part of the premarket clearance process, the FDA reviews the information in the 510(k) submission to determine whether the device proposed to be marketed is substantially equivalent to a predicate device.

The FDA granted clearance of the EXALT Model D Single-Use Duodenoscope to Boston Scientific Corporation.

Related Content

The global X-ray devices market is estimated to grow at a CAGR of 5.14% from a market size of USDX10.793 billion in 2019 to a market size of USD14.580 billion by 2025

Getty Images

News | X-Ray | August 07, 2020
August 7, 2020 — The global X-ray devices mark
Versatile, future-proof digital imaging unit scales to meet growing technology needs of customers
News | Digital Radiography (DR) | August 06, 2020
August 6, 2020 — Carestream Health has launched its...
Ghost imaging approach could enable detailed movies of the heart with low-dose X-rays

Researchers developed a high-resolution X-ray imaging technique based on ghost imaging that can capture the motion of rapidly moving objects. They used it to create a movie of a blade rotating at 100,000 frames per second. Image courtesy of Sharon Shwartz, Bar-Ilan University

News | X-Ray | August 06, 2020
August 6, 2020 — Researche...
New Medical Imaging and Data Resource Center will aid AI development and medical advancement to battle COVID-19

Getty Images

News | Coronavirus (COVID-19) | August 05, 2020
August 5, 2020 — The nation’s largest medical imaging associations are working together to develop the new Medical Im
Mobile CT scanner reimagines head imaging of critically ill patients by enabling patients and staff to remain in ICU
News | Computed Tomography (CT) | August 05, 2020
August 5, 2020 — The Food and Drug Administration (FDA) has cleared the...
Imaging volumes in hospitals and practices previously slowed by the coronavirus pandemic continue to hold steady, according to new QuickPoLL survey results that gauge how radiologists feel about current business and the impact of COVID-19.
Feature | Coronavirus (COVID-19) | August 03, 2020 | By Melinda Taschetta-Millane
Imaging volumes in hospitals and practices previously slowed by the coronavirus pandemic continue to hold steady, acc
According to the new market research report "Radiation Dose Management Market by Products & Services (Standalone Solutions, Integrated Solutions, Services), Modality (Computed Tomography, Nuclear Medicine), Application (Oncology, Cardiology, Orthopedic), End User (Hospitals) - Global Forecast to 2025", published by MarketsandMarkets, the radiation dose management market is projected to reach USD 422.65 million by 2025 from USD 220.22 million in 2020, at a CAGR of 13.9%.

Courtesy of MarketsandMarkets Research

News | Radiation Dose Management | August 03, 2020
August 3, 2020 — According to the new market research report "...
Franco Fontana, CEO of the Esaote Group, and Xie Yufeng, Chairman of WDM.

Franco Fontana, CEO of the Esaote Group, and Xie Yufeng, Chairman of WDM.

News | Digital Radiography (DR) | July 31, 2020
July 31, 2020 — In the thick of the COVID-19 eme