XableCath wins FDA nod for blunt tip support cath for treating PAD

Clinical stage medical device company XableCath said today it won FDA clearance for its blunt tip support vascular catheter.

The Salt Lake City, Utah-based company said the blunt tip catheter is designed to allow for the the true lumen passage of lesions both above and below the knee in the peripheral vasculature for treating peripheral arterial disease.

“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. 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,” Dr. Johannes Dahm at Göttingen, Germany’s Heart & Vascular Center Neu-Bethlehem said in prepared remarks.

“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. XableCath addresses an unmet clinical need, and we believe it will allow us to succeed in treating patients with complex occlusive disease,” Dr. James Benenati of the the Miami Cardiac & Vascular Institute at Baptist Hospital said in a prepared statement.

XableCath said it hopes to perform its 1st US cases with the newly cleared catheter during the first half of next year.

“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 CEO & prez XableCath President and CEO Lisa Dunlea said in a press release.

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