FDA Clears Nexpowder Endoscopic Hemostasis System

FDA Clears Nexpowder Endoscopic Hemostasis System

The US Food and Drug Administration has cleared the Nexpowder endoscopic hemostasis system.

Nexpowder (Medtronic) uses a noncontact, nonthermal, nontraumatic hemostatic powder that is sprayed through a catheter and that features a proprietary powder-coating technology that helps reduce clogging.

This provides improved visibility and control for treating upper gastrointestinal (GI) nonvariceal bleeding, the company explains in a news release.

Nexpowder is sprayed directly on a target site endoscopically through a catheter that connects to a spray handle. Upon contact, it forms a muco-adhesive, durable gel, with or without blood, which degrades in 1 to 3 days.

Because it 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,” the company explains.

In testing, Nexpowder demonstrated a 94% immediate hemostasis rate and a 3.7% rebleeding rate.

More than 1 million endoscopic hemostasis procedures are performed each year in the United States. Upper GI bleeding is one of the most common causes, accounting for 75% of all acute GI bleeding cases, according to Medtronic.

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