XableCath has announced that its XableCath Crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in Europe in two versions, a blunt tip and an abrasion tip, in a variety of diameters and lengths. XableCath received US Food and Drug Administration (FDA) clearance for its crossing devices last year.
Physicians in the USA have had remarkable success using the XableCath Crossing devices to cross challenging lesions in the peripheral vasculature. The product has been used to successfully cross recalcitrant chronic venous obstructions, including what is considered by many clinicians to be the most challenging venous procedures—crossing in-stent restenosis.
“I am pleased XableCath intravascular products continue to demonstrate a high degree of safety and effectiveness crossing a variety of challenging lesions successfully in both venous and arterial disease. Our devices have helped many patients and physicians in the U.S. Now that we have achieved CE mark, we will be able to offer our crossing solution to help patients and healthcare providers in Europe.
In a time where the vast majority of new products are more costly and complex than the technologies they propose to displace, it is especially fulfilling to our team to bring a new product to market that is easy to use, effectively crosses occlusions, and more favorably priced than the existing crossing devices. Economic pressures on our global healthcare system are tremendous and XableCath Crossing devices were conceived to improve patient care at a lower overall procedural cost, which I believe we have achieved,” said XableCath president and chief executive officer, Lisa Dunlea.
“With a CE mark, we look forward to bringing this wonderful, easy to use, and highly applicable interventional device into our Neu-Bethlehemcath-lab in Germany. Our centre conducted the first-in-man studies using the device to recanalise very challenging lesions in patients with no other interventional options and critical limb ischaemia. I am excited to bring it back more fully into my lab to help me and my patients,” said Johannes Dahm, professor of Medicine-Cardiology-Angiology in Göttingen, Germany.