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July 22, 2022

Embolx seeks FDA 510(k) approval for Soldier microcatheter

The new microcatheter will be available in distal outer diameters of 2.0Fr and 2.5Fr.

Embolx has submitted an application seeking 510(k) clearance from the US Food and Drug Administration (FDA) for its new high flow microcatheter product line, known as Soldier.

The new microcatheter uses the Ultra-Thin Wall (UTW) technology that the company initially developed for its Sniper product.

Embolx’s Soldier High Flow Microcatheter has the smallest outer diameter to largest internal lumens, which will make it the most advanced microcatheter in the US.

The combination of UTW technology and unique design innovations allows the new microcatheter to display better torquing, tracking and flow rates.

Soldier will be offered in distal outer diameters of 2.0Fr and 2.5Fr, with working lengths of 130cm, 155cm and 165cm.

The 2.0Fr provides an inner diameter of 0.022in lumen, while the 2.5Fr offers a 0.027in lumen inner diameter.

Embolx president and CEO Michael Allen said: “Soldier is a superior microcatheter by all measures of performance.

“Using our proprietary and patented technology we are expanding our best-in-class catheter products for use in the peripheral vasculature and neurovasculature.”

The company stated that the addition of the Soldier product line will expand its product’s use for all kinds of immunotherapy, embolisation and drug delivery procedures.

At present, Soldier is available in Europe. Its arrival in the US market is anticipated to set a new standard for high flow microcatheters and micro-microcatheters.

Embolx develops microcatheters for arterial embolisation procedures.

In 2018, the company received 510(k) clearance from the US FDA for its pressure-directed arterial embolisation system under the new Sniper Balloon Occlusion Microcatheters range.

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