FDA APPROVES XABLECATH BLUNT TIP SUPPORT CATHETER
XableCath’s blunt tip support catheter has received clearance from the U.S. Food and Drug Administration (FDA). In two clinical investigator-led studies, the device was demonstrated to be a safe, effective, and easy-to-use device, enabling therapeutic options for patients with PAD,” said Johannes Dahm, MD and director of Interventional Cardiology and Angiology and the Heart and Vascular Center Neu-Bethlehem, Göttingen, Germany.
A company spokesman said the blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature. Procedures using the XableCath blunt tip catheters can be performed quickly and safely, allowing physicians to more effectively treat peripheral arterial disease (P.A.D.).
“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,” Dr. Dahm said. “XableCath catheters will be powerful tools in the interventional suite.
“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.”
The company expects to perform its first U.S. cases in the first half of 2018.
James Benenati, medical director, Noninvasive Vascular Laboratory and Fellowship Program Director at the Miami Cardiac and Vascular Institute at Baptist Hospital in Miami, said he will be excited to use the company’s devices in his practice because he believe it will enhance his ability to treat difficult occlusions and ultimately help patients. “The device addresses an unmet clinical need, and we believe it will allow us to succeed in treating patients with complex occlusive disease.”
XableCath president and CEO Lisa Dunlea said the device is 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.
“We believe that our catheters will quickly integrate into standard clinical practice to the benefit of both patients and physicians. With the success of our products in P.A.D., we are excited to apply our innovative technologies to future coronary and atherectomy products.” VTN
READ MORE: XableCath.com