XableCath Crossing Catheters Cleared by the FDA

XableCath Inc. announced that its XableCath blunt and abrasion tip catheters, have been cleared by the U.S. Food and Drug Administration (FDA) as Peripheral Crossing Catheters. The catheters have been safely and successfully used to cross challenging lesions in both arterial CTO’s and chronic obstructive venous lesions. The recent Crossing FDA clearance adds to the previous clearances for endovascular support.
 
“Our catheters are differentiated from other crossing products on the market in a number of meaningful ways. In addition to being successful in crossing tough lesions in both veins and arteries, a versatility no other crossing catheter has demonstrated, the XableCath Crossing Catheters are highly intuitive for physicians to use, do not require training or capital equipment such as a console. In addition, XableCath’s catheters are far more versatile as an interventionalist’s tool since they may also be used as a support catheter to exchange guidewires through,” said XableCath President and CEO Lisa Dunlea. “XableCath’s clinical performance to date has been remarkable, exceeding expectations. It has demonstrated a 95% success rate in crossing arterial lesions and 100 president success in crossing venous lesions. These data have been collected in 11 medical centers in the United States and European Union by vascular surgeons, cardiologists, and interventional radiologist. In over 70 cases, zero complications have been observed related to XableCath usage. This is likely due to the catheter tip design and true-lumen, over-the-wire technology. This crossing catheter is clearly the most intuitive, easiest to use, effective, and safest crossing device currently available. Clinicians continue to express their praise of the flexibility and strong columnar support XableCath provides. The more recent venous experience is most exciting because clinicians now have a device to deal with the recalcitrant chronic venous occlusions; a frequent challenge in the venous space. The Abrasion Tip configuration appears to be ideally suited for these venous lesions.”
 
“As medical director, I look forward to continued success in 2019 and increasing the awareness of our products to practicing physicians performing endovascular procedures,” said Dr. Stephen Lauterbach, a vascular surgeon and XableCath’s medical director.
 
In response to requests by physicians, XableCath is commencing a selective commercial launch this quarter and developing a coronary version of its Crossing Catheter.
 
XableCath was founded in 2014 to commercialize catheters for the treatment of vascular disease. Its revolutionary technology allows effective treatment, improving the lives of patients and transforming the ease of vascular interventions for physicians.