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Support catheter garners FDA clearance for use in peripheral vasculature
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XableCath announced the FDA clearance of its blunt tip support catheter for use in true lumen passage of lesions above and below the knee in the peripheral vasculature.
The catheter (XableCath) is expected to be available for use in the United States in the first half of 2018 and enables operators to treat complex peripheral occlusive disease quickly, safely and effectively, according to a press release from the company.
“In two clinical investigator-led studies, XableCath was demonstrated to be safe, effective, and easy-to-use device, enabling therapeutic options for patients with PAD,” Johannes Dahm, MD, director of interventional cardiology and angiology at the Heart and Vascular Center Neu-Bethlahem, Göttingen, Germany, said the release. “The XableCath blunt tip catheter is unique in its ability to cross CTO quickly while remaining over-the-wire and the true lumen.”
“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,” James Benenati, MD, medical director, Noninvasive Vascular Laboratory and fellowship program director at the Miami Cardiac & Vascular Institute at Baptist Hospital, said in the release. “XableCath addresses an unmet clinical need, and we believe it will allow us to succeed in treating patients with complex occlusive disease.”
Disclosure: Benenati reports receiving personal fees from Penumbra. Cardiology Today’s Intervention was unable to obtain relevant financial disclosures for Dahm.