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FDA approves XableCath’s second catheter

Published 25 May 2018

XableCath has secured clearance from the US Food and Drug Administration (FDA) for its peripheral arterial catheters.

The company said its second catheter, XableCath abrasion tip support catheter, demonstrated safe and effective.

The US regulator approved XableCath blunt tip catheter at the end of 2017, offering peripheral interventionalists a new choice in handling all types of lesions and procedures in the peripheral arterials.

During the first quarter of this year, XableCath performed its initial cases in the US. XableCath expects a full commercial launch in the second half of 2018.

XableCath president and CEO Lisa Dunlea said: “This FDA clearance allows physicians to select between both of XableCath’s unique designs to easily slide past an occluding atheroma through the true lumen of the vessel. It further validates our efforts to deliver safe and effective products for peripheral arterial interventions.”

XableCath medical director Steve Lauterbach said interventionalists can now select the XableCath that is best suited for their patients’ anatomy.

“Both our blunt and abrasion tips have had remarkable initial clinical success in very challenging cases. We look forward to increasing our clinical experience throughout the year,” Lauterbach said.

XableCath was established in 2014 for the commercialization of catheters to treat vascular disease. The company said its technology enables effective treatment, enhancing the lives of patients and transforming the ease of vascular interventions for physicians.

The company said on its website that the abrasion tip catheters facilitate better plaque modulation. The tip design further improves intralumenal plaque modulation, allowing the subsequent passage of therapuetic devices.