The FDA approval covers both the devices in the duodenoscope solution including a single-use endoscope Ambu aScope Duodeno, and a reusable processor unit Ambu aBox Duodeno
Danish diagnostic equipment Ambu has received the US Food and Drug Administration (FDA) 510(k) approval for its sterile, single-use duodenoscope, dubbed Ambu aScope Duodeno.
The company’s duodenoscope solution comprises a single-use endoscope Ambu aScope Duodeno, and a reusable processor unit Ambu aBox Duodeno.
With FDA approval, which covers both the devices, the company is now ready for commercial launch of the solution, which is designed to help increase patient safety and prevent duodenoscope infections.
Ambu CEO Juan Jose Gonzalez said: “At Ambu, we are determined to advance patient safety through innovative design of single-use devices, and we are excited to improve safety for the 2 million patients each year who require an ERCP (Endoscopic Retrograde Cholangio-Pancreatography) procedure.
“It’s no longer necessary to balance the necessity of the procedure against the risk of infection from a reusable endoscope. Now, both doctor and patient can focus on diagnosis and treatment by using a sterile, single-use duodenoscope.”
Reusable duodenoscopes increasingly criticised by the FDA
Duodenoscopes are generally used for visual examinations of the duodenum and plays crucial role in the diagnosis and treatment of conditions such as gallstones, pancreatitis, tumors or cancer in the bile ducts or the pancreas.
The medical device maker said that the reusable duodenoscopes have been increasingly criticised by the FDA in recent years, due to the cases of device-related infections and patient fatalities.
The US regulatory agency has recommended duodenoscope manufacturers and healthcare facilities in August 2019, to help transition to duodenoscopes that are partially or completely single-use.
Following the FDA approval, Ambu intends to begin a post-market clinical trials programme in 500 patients at multiple centres in the US, with results from sub-set of the study during the first quarter of the company’s financial year 2020-21.
Furthermore, Ambu is planning to introduce 15 new devices across all major areas of endoscopy over the next three years, including three additional devices for GI specialists, a colonoscope, a gastroscope and a cholangioscope.
Ambu marketing vice president Jens Kemp said: “The aScope Duodeno is sterile, single-use and seamlessly integrates into existing hospital systems and offers an intuitive, lightweight design with similar functionality to reusable duodenoscopes.
“Over the past six months, we have expanded our sales organization and built a dedicated commercial infrastructure for gastroenterology. After today’s FDA clearance, we will now approach our customers to arrange product demonstrations, set up evaluations and promote what Ambu has to offer within the field of GI.”