COLUMBIA, Md.--(BUSINESS WIRE)--Ambu Inc., the world leader in single-use endoscopy, announced today that an Ohio gastroenterologist has become the first physician in the U.S. to use Ambu’s new sterile, single-use duodenoscope in 100 endoscopic retrograde cholangiopancreatography (ERCP) procedures.
Dr. Juan Tejada, a gastroenterologist and advanced endoscopist at Memorial Health System in Marietta, Ohio, recently began using Ambu’s aScope Duodeno™, calling it a “win” for both physicians and patients.
“Part of the art of saving lives while using technology is to know when the right time is to change to something simpler, while continuing to keep in mind the human being behind the process,” Dr. Tejada said in a press release, which was covered by the Marietta Times. “I believe that single-use duodenoscopes move us in this direction.”
Memorial Health System, which operates hospitals in Marietta, Ohio, and health facilities across southeastern Ohio and northwestern West Virginia, also becomes the first hospital system in the U.S. to adopt Ambu’s aScope Duodeno.
“We are thrilled that Memorial Health System and Dr. Tejada have embraced Ambu’s sterile single-use aScope Duodeno and have already used it successfully on many patients,” Jens Kemp, Vice President of Marketing at Ambu Inc., said. “The aScope Duodeno demonstrates our commitment to improving safety for the millions of patients each year who require an ERCP. Our single-use endoscopes eliminate infection and cross-contamination risk.”
Duodenoscopes are used for visual examinations of the duodenum and play a key role in the diagnosis and treatment of conditions such as gallstones, pancreatitis, tumors, or cancer in the bile ducts or the pancreas. In the U.S., there are an estimated 600,000 procedures using duodenoscopes conducted annually.
Reusable duodenoscopes have come under increasing scrutiny from the U.S. Food and Drug Administration in recent years because there have been cases of device-related infections and patient fatalities. In August 2019, the FDA recommended duodenoscope manufacturers and healthcare facilities transition to duodenoscopes that are partially or completely single use.
The Ambu aScope Duodeno received 510(k) clearance in July 2020 by the FDA and was granted Breakthrough Device Designation, which is given to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening conditions. This year, the aScope Duodeno was named a Red Dot award winner for product design.
Ambu continues to enhance the aScope Duodeno and has embarked on a rapid innovation cycle based on modular design, a focus on research and development, and physician testing and feedback. As a result, the company expects a second-generation aScope Duodeno to debut this fiscal year. In addition to the aScope Duodeno, Ambu’s single-use gastroscope system, the aScope™ Gastro and aBox™ 2, have been submitted for FDA clearance.
About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific. For more information, please visit ambu.com or ambuUSA.com. Follow us on Facebook, Twitter, LinkedIn, or YouTube and subscribe to our podcast “Endoscopy Insights.”
