FDA Approves Catheter for Use in PAD


Submitted on Wed, 01/10/2018 - 11:45

The XableCath blunt tip support catheter has been approved by the US Food and Drug Administration (FDA). The catheter is indicated for treatment of peripheral arterial disease (PAD), and it is designed to aid in true lumen passage of lesions, both above and below the knee, in the peripheral vasculature.

The approval was based on two studies led by clinical investigators. The study results showed that the catheter is “a safe, effective, and easy-to-use device, enabling therapeutic options for patients with PAD,” said Johannes Dahm, M.D., Director of Interventional Cardiology & Angiology, Heart & Vascular Center Neu-Bethlehem, Göttingen, German, in a statement. He added, “The XableCath blunt tip catheter is unique in its ability to cross chronic total occlusions quickly while remaining over-the-wire and in the true lumen. XableCath catheters will be powerful tools in the interventional suite.”

The company’s CEO and president further commented, “ “Different from most interventional devices used to facilitate lesion passage, XableCath was designed to be one of the best support catheters and to facilitate over-the-wire lumen passage, minimizing the need for multiple products and exchanges and reducing procedure time.”

According to the company, the first cases in the United States with the new catheter are expected to be performed during the first half of 2018.


XableCath Receives FDA Clearance for Broadly Effective Catheter Aimed at Peripheral Arterial Disease Market [press release]. Salt Lake City, UT: Business Wire.