Charles Sternberg, Associate Editor09.30.22
The U.S. Food and Drug Administration has cleared Medtronic’s Nexpowder endoscopic hemostasis system.
Developed independently by Next Biomedical Inc. (Korea) and distributed globally by Medtronic, Nexpowder uses a noncontact, nonthermal and nontraumatic hemostatic powder sprayed through a catheter that has a propriety powder-coating technology for minimized clogging which provides improved visibility and control1,2 for treating upper gastrointestinal nonvariceal bleeding.
There are more than one million endoscopic hemostasis procedures performed every year in the United States and upper GI bleeding is one of the most common causes, accounting for 75% of all acute GI bleeding cases.4
“We are very excited to bring the innovative, Nexpowder system to gastroenterologists. 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,”4 said Gio Di Napoli, president of the Gastrointestinal business, part of the Medical Surgical Portfolio at Medtronic. “The Medtronic GI business is striving – across all products in our portfolio – to create transformative technologies that improve outcomes and change the standard of care.”
“With a 94% immediate hemostasis rate and a 3.7% rebleeding rate, we’re thrilled to share this effective technology with gastroenterologists,”2 said Dr. Austin Chiang, M.D., M.P.H., chief medical officer of the Gastrointestinal business at Medtronic. “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.”
Created with a unique delivery system that doesn’t require CO2 or air compressors, the Nexpowder endoscopic hemostasis system combats the inefficiency of clogged catheters and cloudy fields of vision with a proprietary hydrophilic polymer to enable controlled delivery, minimize catheter clogging and maintain endoscopic visibility.3 The system responds to all types of moisture, not only blood.
References:
1 Park JS, Bang BW, Hong SJ, et al. Efficacy of a novel hemostatic adhesive powder in patients with refractory upper gastrointestinal bleeding: a pilot study. Endoscopy. 2019 May;51(5):458-462
2 Park JS, Kim HK, Shin YW, et al. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Endosc Int Open. 2019 Dec;7(12):E1763-E1767
3 Bang B, Lee E, Maeng J, et al. Efficacy of a novel endoscopically deliverable muco-adhesive hemostatic powder in an acute gastric bleeding porcine model. PLoS One. 2019 Jun 11;14(6):e0216829
4 Antunez, C. Upper Gastrointestinal Bleeding. NCBI Bookshelf, A Service of the National Library of Medicine, National Institutes of Health, July 2020
Developed independently by Next Biomedical Inc. (Korea) and distributed globally by Medtronic, Nexpowder uses a noncontact, nonthermal and nontraumatic hemostatic powder sprayed through a catheter that has a propriety powder-coating technology for minimized clogging which provides improved visibility and control1,2 for treating upper gastrointestinal nonvariceal bleeding.
There are more than one million endoscopic hemostasis procedures performed every year in the United States and upper GI bleeding is one of the most common causes, accounting for 75% of all acute GI bleeding cases.4
“We are very excited to bring the innovative, Nexpowder system to gastroenterologists. 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,”4 said Gio Di Napoli, president of the Gastrointestinal business, part of the Medical Surgical Portfolio at Medtronic. “The Medtronic GI business is striving – across all products in our portfolio – to create transformative technologies that improve outcomes and change the standard of care.”
How It Works
Nexpowder is sprayed on to a target site endoscopically through a catheter that connects to a spray handle. Once sprayed, Nexpowder immediately forms a muco-adhesive and durable gel upon contact, with or without blood, which degrades in one-to-three days. The spray adheres to the tissue with double the adhesive force of other commercially available products, resulting in a durable hemostatic effect.1,2,3 Nexpowder delivers a precise solution for nonvariceal upper GI bleeding with minimal scattering or clogging, enabling direct endoscopic visibility without impairment.“With a 94% immediate hemostasis rate and a 3.7% rebleeding rate, we’re thrilled to share this effective technology with gastroenterologists,”2 said Dr. Austin Chiang, M.D., M.P.H., chief medical officer of the Gastrointestinal business at Medtronic. “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.”
Created with a unique delivery system that doesn’t require CO2 or air compressors, the Nexpowder endoscopic hemostasis system combats the inefficiency of clogged catheters and cloudy fields of vision with a proprietary hydrophilic polymer to enable controlled delivery, minimize catheter clogging and maintain endoscopic visibility.3 The system responds to all types of moisture, not only blood.
References:
1 Park JS, Bang BW, Hong SJ, et al. Efficacy of a novel hemostatic adhesive powder in patients with refractory upper gastrointestinal bleeding: a pilot study. Endoscopy. 2019 May;51(5):458-462
2 Park JS, Kim HK, Shin YW, et al. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Endosc Int Open. 2019 Dec;7(12):E1763-E1767
3 Bang B, Lee E, Maeng J, et al. Efficacy of a novel endoscopically deliverable muco-adhesive hemostatic powder in an acute gastric bleeding porcine model. PLoS One. 2019 Jun 11;14(6):e0216829
4 Antunez, C. Upper Gastrointestinal Bleeding. NCBI Bookshelf, A Service of the National Library of Medicine, National Institutes of Health, July 2020