- Danish medtech Ambu said Friday it received FDA clearance and is ready to launch a single-use duodenoscope.
- The 510(k) clearance comes about seven months after the agency greenlit a device from Boston Scientific it said was the first fully disposable duodenoscope to come to market.
- FDA last year encouraged healthcare providers to make the switch to single-use duodenoscopes from reusable versions of the devices, used in procedures to diagnose and treat pancreas and bile duct problems, after reviewing evidence that the latter can cause infections.
The typically reusable flexible tube devices used in GI procedures — half a million endoscopic retrograde cholangiopancreatography, or ERCP, procedures per year, according to FDA — can be a host for potentially deadly infection.
FDA held an advisory panel meeting on the issue last year and in August encouraged healthcare providers to switch to versions of the devices with disposable parts. Companies like Pentax and GI Scientific launched disposable pieces attempting to make reusable scopes safer, but at the time, no fully disposable duodenoscopes were available.
According to Ambu, its device consists of a single-use scope and a reusable processor unit, both covered by the FDA clearance. It was developed with help from the engineering team at Invendo Medical, which Ambu acquired in 2017 for its single-use endoscopy technology, and builds on the company's first-to-market single-use flexible bronchoscope in 2009, the company said.
As more evidence came to light last year of the contamination risks associated with reusable duodenoscopes, Ambu struck an agreement with Bloomington, Indiana-based Cook Medical, which said last May it would distribute the device in the U.S. once it received FDA clearance. That agreement changed when Ambu opted to build out its own GI sales force over the last six months and lead commercialization of the device itself. Starting last November, Cook and Ambu put in place a global marketing agreement instead.
As for its pipeline, Ambu says it plans to launch 15 new devices across endoscopy in the next three years, including single-use versions of a colonoscope, a gastroscope and a cholangioscope. Since the onset of the pandemic, the company has also highlighted a potential new need for safer bronchoscope, citing research that contaminated reusable bronchoscopes may put COVID-19 patients at risk.
Boston Scientific bet big on the transition to single-use duodenoscopes, previously estimating the market potential for its Exalt Model D device to be worth more than $1 billion. Having received 510(k) clearance for the device at the end of 2019, Boston Scientific planned a limited rollout in the first quarter with a gradual scale-up in the second quarter and second half of the year. But the timing of that first quarter launch meant the sales push was partly thwarted by the onset of the pandemic, which limited reps' access to hospitals.
Still, Boston Scientific scored a win for the device when CMS OK'd transitional pass-through payment status for the company's broader category of single-use endoscopes. That development means the Exalt D device is eligible for reimbursement despite the fact cost data is still being collected by the agency. Starting July 1, the device could be billed for under a new code when used to treat Medicare patients in the hospital outpatient setting.