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XableCath gets FDA clearance for blunt tip catheter

Published 19 December 2017

XableCath announced its blunt tip support catheter has received clearance from the US Food and Drug Administration (FDA).

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 (PAD).

“In two clinical investigator-led studies, XableCath was demonstrated to be 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, Germany.

 “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 expects to perform its first U.S. cases in the first half of 2018.

“I am excited to use the XableCath devices in my practice, because I believe it will enhance our ability to treat difficult occlusions and ultimately help our patients,” said James Benenati, M.D., Medical Director, Noninvasive Vascular Laboratory and Fellowship Program Director at the Miami Cardiac & Vascular Institute at Baptist Hospital in Miami, Florida.

“XableCath 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 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.

“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 PAD, we are excited to apply our innovative technologies to future coronary and atherectomy products.”

XableCath was founded in 2014 to commercialize catheters for the treatment of vascular disease. XableCath technology is revolutionary and allows effective treatment, improving the lives of patients and transforming the ease of vascular interventions for physicians.



Source: Company Press Release