FDA clears Medtronic gastrointestinal bleeding solution

Medtronic received FDA clearance for its gastrointestinal bleeding solution, Nexpowder. 

Nexpowder is a noncontact, nonthermal and nontraumatic powder that can treat upper gastrointestinal bleeding, according to a Sept. 28 news release from the company shared with Becker's

Seventy-five percent of all acute GI bleeding cases are caused by endoscopic hemostasis, which sees 1 million cases performed yearly, the release said. 

"In addition to Nexpowder reacting to moisture and not just blood, this technology also addresses the shortcomings of the existing technology that is out there, like poor visualization," Austin Chiang, MD, chief medical officer of the gastrointestinal business at Medtronic, told Becker's.

"The way that existing technologies work, visibility is very limited. It is very frustrating as a gastroenterologist to not be able to see what you are doing, and so we don't have that issue with Nexpowder. Also, the device doesn't get clogged as easily because of how the spray is delivered." 

Nexpowder can be sprayed on using a catheter and a spray handle, and it immediately forms a mucoadhesive gel on contact, with or without blood. It degrades in one to three days.

The product launched in the European market 12 months ago, and Medtronic has been collecting survey data from users and physicians. 

"We launched this technology in Europe already last year, and we have received great feedback," Gio Di Napoli, president of the gastrointestinal business at Medtronic, told Becker's. "We are looking forward to the same in the U.S."

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