XableCath Crossing Catheters cleared by FDA

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XableCath, Inc. has announced that its blunt and abrasion tip catheters have been cleared by the US Food and Drug Administration (FDA) as peripheral crossing catheters. The catheters have been safely and successfully used to cross challenging lesions in both arterial chronic total occlusions (CTOs) and chronic obstructive venous lesions. The recent 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 chief executive officer, 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% success in crossing venous lesions. These data have been collected in 11 medical centres in the USA and EU by vascular surgeons, cardiologists, and interventional radiologist. In over 70 cases, zero complications have been observed related to usage of the device. 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 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.


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