ReFlow announces 510(k) clearance and US clinical use of the SpeX shapeable support catheter


ReFlow Medical has announced FDA clearance for US commercialisation of its SpeX shapeable support catheter for use in the peripheral vasculature and the first US clinical cases with the device.

The initial US cases were performed by John R Laird at the UC Davis Vascular Center in Davis, California, USA. 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.”

ReFlow medical chief operating officer, John Fulkerson, comments: “The SpeX shapeable catheter was designed with input from our scientific advisory board. After multiple iterations and designs, it became clear that empowering physicians with the ability to shape and maintain their own angle was the most effective solution for them.”