FDA Clears XableCath Catheter for Peripheral Arterial Disease
December 18, 2017—XableCath announced that its XableCath blunt-tip support catheter has received clearance from the US Food and Drug Administration. The device facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature.
In the company's announcement, James Benenati, MD, said, "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. Benenati is Medical Director, Noninvasive Vascular Laboratory and Fellowship Program Director at the Miami Cardiac & Vascular Institute at Baptist Hospital in Miami, Florida.
Johannes Dahm, MD, added, “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 peripheral artery disease. 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. Dahm is Director of Interventional Cardiology & Angiology, Heart & Vascular Center Neu-Bethlehem, Göttingen, Germany.
The company expects the first United States cases to be performed in the first half of 2018.