UTW

New Soldier® High Flow Microcatheter Granted FDA Clearance

Retrieved on: 
Thursday, February 29, 2024
Cardiology, Pharmaceutical, Surgery, Oncology, Health, FDA, Medical Devices, Health Technology, Multimedia, Food, UTW, Physician, Soldier, Inc.

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.

Key Points: 
  • 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.
  • View the full release here: https://www.businesswire.com/news/home/20240229385059/en/
    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®.
  • 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.

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

Retrieved on: 
Thursday, July 21, 2022
Food, CEO, Sniper, Uterine fibroid, UTW, Immunotherapy, Technology, FDA, Paediatric-use marketing authorisation, Soldier, Food and Drug Administration, Medical imaging, Silicon

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.

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.