Technology | December 18, 2014

FDA Clears ReFlow SpeX Shapeable Support Catheter

Physicians can shape catheter tip to preferred angle, maintain angle throughout procedure

ReFlow Medical Inc., SpeX shapeable support catheter, FDA

Image courtesy of ReFlow Medical Inc.

December 17, 2014 — ReFlow Medical Inc. announced U.S. Food and Drug Administration (FDA) clearance for commercialization of their SpeX shapeable support catheter in the United States for use in the peripheral vasculature, as well as the first American clinical cases with the device. The initial United States cases were performed by John R. Laird, M.D., at the University of California-Davis Vascular Center.

The SpeX shapeable support catheter enables physicians to shape the tip of the support catheter to their preferred angle to meet the specific needs of the case and maintain that angle throughout the procedure. It is designed to be compatible with physician-preferred .035 guidewires and the Wingman14 crossing catheters.

“I was very pleased with the flexibility to be able to shape my own angle with the SpeX catheter during my procedures. I can see the SpeX catheter becoming a useful tool in my practice as a standalone catheter and in combination with the Wingman14 crossing catheter,” says Laird. “It’s always rewarding to see clinical feedback lead to new technologies that answer unmet needs. With the extendable tip option of the Wingman Crossing Catheters and now the unique shapeable and maintainable tip option of the SpeX catheters, ReFlow Medical continues to fill the needs of our peripheral toolbox.”

For more information: www.reflowmedical.com

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