Endoscopic hemostasis system cleared by FDA for nonvariceal upper GI bleeding
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The FDA granted clearance to Medtronic’s endoscopic hemostasis system, Nexpowder, intended to improve visibility and management of upper gastrointestinal bleeding not linked to varices, according to a company press release.
“We are very excited to bring the innovative Nexpowder system to gastroenterologists,” Gio Di Napoli, president of gastrointestinal business at Medtronic, said in the release. “We considered the potential impact on physicians and patients alike by meeting a clear need to reduce mortality from upper GI bleeding, a condition that causes death for one out of every 1,000 people while also reducing rebleeding, which happens in 20% of all upper GI bleeding cases.”
As a noncontact, nonthermal and nontraumatic hemostatic powder, Nexpowder is sprayed on the target site endoscopically and forms a muco-adhesive gel that degrades within 1 to 3 days. The hydrophilic polymer base, acting as an adhesive barrier against upper GI bleeds as well as other bodily fluids, is intended to overcome the challenges of clogged catheters and preserving endoscopic visibility during the procedure.
“With a 94% immediate hemostasis rate and a 3.7% rebleeding rate, we’re thrilled to share this effective technology with gastroenterologists,” Austin Chiang, MD, MPH, chief medical officer of gastrointestinal business at Medtronic, noted. “When we treat patients, we’re looking for immediate and lasting results when it matters most. The Nexpowder system is a powerful tool for GI professionals to add to their toolboxes.”
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