New Soldier® High Flow Microcatheter Granted FDA Clearance

February 29, 2024 |

2 min read

Embolx Inc. is thrilled to announce that the U.S. Food and Drug Administration has granted clearance for the Soldier® High Flow Microcatheter, advancing localized drug delivery in vascular interventions.

FDA Clears Soldier Microcatheter for Localized Drug Delivery in Vascular Interventions

SUNNYVALE, Calif.--(BUSINESS WIRE)-- Embolx Inc., a leading medical technology company developing microcatheters for arterial embolization procedures, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted clearance for the Soldier® High Flow Microcatheter, advancing localized drug delivery in vascular interventions.

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Embolx Soldier High Flow Microcatheter - Received FDA Clearance (Photo: Business Wire)

The Soldier microcatheter is a cutting-edge medical device created using the same Ultra-Thin Wall (UTW) technology and advanced design initially developed for its flagship product Sniper®. UTW technology allows microcatheters to be smaller in outer diameter yet maintain the largest internal lumens improving flow rates by almost two times. Using multiple discrete longitudinal sections, the advanced design provides exceptional pushability, torquability, and trackability. With FDA clearance, Embolx introduces a new microcatheter platform technology that is now the basis for a pipeline of new products.

“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 embolization procedures,” said Michael Allen, CEO and President of Embolx. “We will continue to develop innovative and unique products that provide creative solutions to therapy delivery.”

The Soldier microcatheter combines the properties of larger catheters in a smaller profile. Physicians will no longer be compelled to sacrifice image quality, distal reach, or range of embolic agents when selecting a 2 Fr catheter. The catheter’s exceptional torque response and radiopaque distal tip provide accurate curved tip placement and visualization of rotation position.

Soldier will be available in 2 Fr and 2.5 Fr and will come in three lengths – 130 cm, 155 cm, and 165 cm. The 2 Fr offers a 0.022” lumen and the 2.5 Fr offers a 0.027” lumen. With this clearance, Embolx aims to refine physicians’ overall experience using microcatheters while creating an innovative platform for future products.

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 contact Haley McGregor at hmcgregor@embolx.com or call (408) 990-2949.