FDA Clears ReFlow Medical's Spex Shapeable Support Catheter

December 17, 2014—ReFlow Medical, Inc. announced US Food and Drug Administration clearance for commercialization of the company’s Spex shapeable support catheter for use in the peripheral vasculature. The company also announced that the first United States clinical cases with the device were performed by John R. Laird, MD, at the University of California Davis Vascular Center in Davis, California. 

According to the company, 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 0.035-inch guidewires and the ReFlow Wingman14 crossing catheters.

Dr. Laird commented in the company’s press release, “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.” He added, “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.”