MetaMedical™ Solutions Inc

FDA approves Embolx’s Soldier High Flow Microcatheter

The US Food and Drug Administration (FDA) has granted clearance for Embolx’s Soldier High Flow Microcatheter, a new medical device designed to enhance localised drug delivery during vascular interventions.

The microcatheter offers improved flow rates and utilises the same Ultra-Thin Wall (UTW) technology and advanced design as the company’s Sniper product.

The UTW technology allows for a smaller outer diameter while maintaining the largest internal lumens, effectively doubling flow rates.

Featuring multiple discrete longitudinal sections, the microcatheter’s design ensures enhanced pushability, torquability, and trackability.

The Soldier microcatheter’s design enables it to embody the capabilities of larger catheters within a more compact form. Physicians can now utilise a 2Fr catheter without compromising on image quality, distal reach, or the selection of embolic agents.

The catheter’s torque response and radiopaque distal tip ensure precise placement and clear visualisation of the rotation position.

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Embolx CEO and president Michael Allen said: “The FDA clearance of the Soldier microcatheter represents a significant milestone in the evolution of advanced microcatheters. With this cutting-edge technology, it is now possible to use smaller microcatheters for more embolisation procedures.

“We will continue to develop innovative and unique products that provide creative solutions to therapy delivery.”

Available in both 2Fr and 2.5Fr sizes, the Soldier microcatheter will be offered in three different lengths: 130cm, 155cm, and 165cm. The 2Fr version features a 0.022in lumen while the 2.5Fr version has a 0.027in lumen.

In November 2023, Embolx and advanced medical equipment distributor Girlow USA teamed up to expand access to the former’s medical technologies into South America.

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