ReFlow Medical has obtained 510(k) approval from the US Food and Drug Administration for its SpeX Shapeable Support Catheter for use in the peripheral vasculature.
The newly approved catheter allows 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.
ReFlow Medical COO John Fulkerson said: "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."
The SpeX Shapeable Support Catheter has been designed to be compatible with physician preferred .035 guidewires and the Wingman14 Crossing Catheters.
ReFlow noted that the initial US cases were performed by Dr John Laird at the UC Davis Vascular Center in Davis, California.
Dr Laird said: "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."
Image: ReFlow Medical’s SpeX Shapeable Support Catheter. Photo: courtesy of ReFlow Medical, Inc.