Embolx Files 510(k) for New Soldier® High Flow Microcatheter

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SUNNYVALE, Calif., July 21, 2022 /PRNewswire/ -- Embolx, Inc. a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has filed a 510(k) to the Food and Drug Administration (FDA) for its new product line of high flow microcatheters called "Soldier," that uses the same Ultra-Thin Wall (UTW) technology initially developed for its flagship product Sniper®. UTW technology allows microcatheters to be smaller in outer diameter yet maintain the largest internal lumens on the market. UTW in combination with unique design innovations enables Soldier to display best-in-class tracking, torquing, and flow rates. Currently available in the European market, Soldier's highly anticipated arrival in the United States market is expected to shift the paradigm and set a new standard for both high flow microcatheters and micro-microcatheters.

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Provider:

PR Newswire

Retrieved on:

Thursday, July 21, 2022

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Tags:

Food, CEO, Sniper, Uterine fibroid, UTW, Immunotherapy, Technology, FDA, Paediatric-use marketing authorisation, Soldier, Food and Drug Administration, Medical imaging, Silicon

Geotags:

CALIFORNIA, UNITED STATES

Organisation:

EMBOLX

Summary

Key Points:

UTW in combination with unique design innovations enables Soldier to display best-in-class tracking, torquing, and flow rates.
The Soldier microcatheter will be available in 2.0 Fr and 2.5 Fr and will come in three lengths 130 cm, 155 cm, and 165 cm.
The addition of the Soldier product line will expand the use of Embolx products for all types of embolization, immunotherapy, and drug delivery procedures.
Embolx is committed to dramatically improving the treatment of various conditions, including cancerous tumors, benign prostatic hyperplasia, and uterine fibroids.

Embolx Files 510(k) for New Soldier® High Flow Microcatheter

New Catheter with Ultra-Thin Wall Technology Offers Smallest Outer Diameter with Largest Inner Diameter, Making it the Most Advanced Microcatheter in the US Market

SUNNYVALE, Calif., July 21, 2022 /PRNewswire/ -- Embolx, Inc. a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has filed a 510(k) to the Food and Drug Administration (FDA) for its new product line of high flow microcatheters called "Soldier," that uses the same Ultra-Thin Wall (UTW) technology initially developed for its flagship product Sniper®. UTW technology allows microcatheters to be smaller in outer diameter yet maintain the largest internal lumens on the market. UTW in combination with unique design innovations enables Soldier to display best-in-class tracking, torquing, and flow rates. Currently available in the European market, Soldier's highly anticipated arrival in the United States market is expected to shift the paradigm and set a new standard for both high flow microcatheters and micro-microcatheters.

Soldier is a superior microcatheter by all measures of performance.

"Soldier is a superior microcatheter by all measures of performance," said Michael Allen, President, and CEO of Embolx Inc. "Using our proprietary and patented technology we are expanding our best-in-class catheter products for use in the peripheral vasculature and neurovasculature."

The Soldier microcatheter will be available in 2.0 Fr and 2.5 Fr and will come in three lengths – 130 cm, 155 cm, and 165 cm. The 2.0 Fr offers an 0.022" lumen and the 2.5 Fr offers an 0.027" lumen. The addition of the Soldier product line will expand the use of Embolx products for all types of embolization, immunotherapy, and drug delivery procedures.

About Embolx, Inc.

Embolx is an emerging commercial-stage medical device company in Silicon Valley developing microcatheters for arterial embolization procedures. Embolx is committed to dramatically improving the treatment of various conditions, including cancerous tumors, benign prostatic hyperplasia, and uterine fibroids. For more information, please visit www.embolx.com.

Media Contact:
Haley McGregor
[email protected]

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SOURCE Embolx