FDA says Boston Scientific's new single-use scope a step forward in safety

With encouragement from the U.S. Food and Drug Administration, medical device maker Boston Scientific Corp. will start selling single-use medical scopes next year that retail for a few thousand dollars to address concerns that reusable devices can spread deadly pathogens.

Boston Scientific, which employs about 8,000 people in Minnesota, announced Friday afternoon that it received clearance from the FDA to begin selling its new Exalt Model D duodenoscope in the first quarter of 2019. Although the company has declined to release the exact pricing, it has told investors that its pricing strategy may improve overall cost effectiveness for the scoping procedure known as ERCP.

Boston Scientific's Exalt Model D is the first device to receive U.S. sales approval since the FDA announced earlier this year that doctors, hospitals and device companies should start to transition away from using devices and components that have to be washed to avoid spreading disease-causing germs between patients.

Duodenoscopes are inserted down the throat to examine and treat problems of the pancreas, gallbladder and bile ducts, like when a gallstone or cancerous growth obstructs a duct or the pancreas becomes chronically inflamed.

Dr. Jeff Shuren, director of the FDA's medical device division, said traditional duodenoscopes are used in the U.S. in at least 500,000 procedures a year.

"The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices," Shuren said in an FDA announcement about the clearance. "A fully disposable duodenoscope doesn't need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing."

The company expects the scope to be among its strongest growth drivers next year, and potentially surpass $1 billion in annual sales. The device was cleared by the FDA for ERCP, or endoscopic retrograde cholangiopancreatography.

Though single-use ERCP scopes and supplies are enjoying vocal support from the FDA today, Boston Scientific CEO Mike Mahoney told investors in October that his product teams deserved kudos "for really identifying this opportunity nearly three or four years ago."

In 2013, the Centers for Disease Control and Prevention told the FDA about a "potential" association between duodenoscopes and the transmission of multidrug-resistant bacteria, though Reuters later reported that the FDA knew as early as 2009 that the devices could spread fatal infections.

The FDA ordered the three manufacturers of reusable duodenoscopes — Fujifilm Medical Systems USA, Olympus Medical Systems Corp. and Pentax of America — to conduct new studies of cleaning practices and their impact on scope-associated infections. The agency eventually discovered some of the scopes have features like narrow grooves and hinges that were prone to "retaining debris and biological material."

"Duodenoscopes have several moving parts at the end of the scope that are very difficult to clean. And of course, you're in the GI tract of very sick patients when you're doing these procedures, so you're picking up all kinds of bugs, and so they need to be thoroughly cleaned," Boston Scientific endoscopy President Art Butcher told investors in a December conference call, according to a Seeking Alpha transcript.

"There is a great unmet need for a duodenoscope that will universally and assuredly be a 100% sterile and safe every time."

Boston Scientific did not release pricing information for the Exalt Model D, which is expected to cost between $2,000 and $3,000 per device. Device companies typically don't publicly disclose prices paid by hospitals.

But Boston Scientific executives did tell investors in a June 2018 webcast that the device could improve the overall "cost effectiveness" of ERCP procedures, while minimizing hospitals' capital investments.

A study in gastroenterology journal Gut reported in February that the nine traditional duodenoscopes at one large hospital cost about $35,000 each and lasted for three years.

Those costs did not include $1,500 in annual maintenance, $8,000 for a scope-washing machine, $10,000 for cleaning supplies and filters, tens of thousands in labor costs, and $125,000 per scope-related infection in the 1% or less of cases in which that happened.

Dr. V. Raman Muthusamy, medical director for endoscopy at UCLA Health and lead author of a positive early study of the Exalt scope, noted that the costs of ERCP procedures will rise no matter what happens.

Traditional scopes are becoming more costly to maintain because of enhanced cleaning requirements and new single-use components for durable scopes.

At least early on, Muthusamy said patients with compromised immune systems or those already colonized with multidrug resistant infections might be particularly good candidates for a single-use device.

"I think this really represents a milestone in endoscopy," he said, citing past milestones like the move to flexible scopes, and the evolution to scopes with high-definition displays.

"There is potential to go from reusable devices to high-quality single-use devices. I think, in that sense, it represents an important step forward."

Joe Carlson • 612-673-4779