Medtronic (NYSE:MDT) announced that it received FDA clearance for its Nexpowder endoscopic hemostasis system.
Nexpowder uses a noncontact, nonthermal and nontraumatic hemostatic powder. The powder sprays through a catheter that features a proprietary powder-coating technology for minimized clogging.
The Nexpowder design provides improved visibility and control in the treatment of upper gastrointestinal (GI) nonvariceal bleeding. According to a news release, upper GI bleeding accounts for 75% of all acute GI bleeding cases.
“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,” said Gio Di Napoli, president of the Gastrointestinal business 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 onto a target site endoscopically through the catheter, which connects to a spray handle. Once sprayed it forms a mucoadhesive and durable gel upon contact, with or without blood. The gel then degrades in one-to-three days.
The spray adheres to the tissue with double the adhesive force of other commercially available products, Medtronic said. This results in a durable hemostatic effect. Altogether, the company said Nexpowder provides a solution for nonvariceal upper GI bleeding with minimal scattering or clogging, enabling direct endoscopic visibility without impairment.
Nexpowder also doesn’t require CO2 or air compressors. Its proprietary hydrophilic polymer enables controlled delivery to minimize clogging and maintain endoscopic visibility.
“With a 94% immediate hemostasis rate and a 3.7% rebleeding rate, we’re thrilled to share this effective technology with gastroenterologists,” said Dr. Austin Chiang, CMO 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.”