FDA Approved XableCath Blunt Tip for True Lumen Passage of Lesions
XableCath received FDA approval for its XableCath blunt tip support catheter for crossing calcified lesions in the peripheral vasculature above and below the knee.
XableCath is a medical device innovator company. It is focused on providing design leadership, industry expertise, and resources to bring new products in market. It has received the US Food and Drug Administration (FDA) approval on December 22, 2017 for its blunt tip support catheter. It results in a tunnel through the lesion, which aid in placement of stents or other therapies. The device is offered in six size combinations. The width ranges from 0.014 to 0.035 and lengths from 65 cm to 145 cm.
According to Vascular Grafts Market report published by Coherent Market Insights, vascular grafts are medical devices used to bypass the infected or diseased blood vessels. They can replace injured blood vessels, veins, and arteries to substitute hard blood vessels or valves. Blood flow is redirected from one place to another by introducing a graft with the help of surgical reconstruction process. They are majorly used in treatment of cardiovascular diseases by surgical procedures such as bypass grafting. The graft is surgically inserted at the required site to bypass the damaged or diseased blood vessels
“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.”
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