Embolx, a medical device company developing microcatheters for arterial embolization procedures to treat cancerous tumours, benign prostatic hyperplasia, and uterine fibroids, has announced that the company has filed a 510(k) to the US Food and Drug Administration (FDA) for its new line of high-flow microcatheters, Soldier. It 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 possible internal lumens. UTW, in combination with Soldier’s unique design, enables it to display best-in-class tracking, torquing, and flow rates. Currently available in Europe, Soldier’s arrival on the US 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,” said Michael Allen, president, and chief executive officer of Embolx.”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 2.0Fr and 2.5Fr and will come in three lengths—130cm, 155cm, and 165cm. The 2.0Fr offers an 0.022″ lumen and the 2.5Fr 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.