XableCath recently announced its Crossing Catheters received CE Mark approval for peripheral use.
The crossing devices come in blunt tip and abrasion tip versions with a variety of diameters and lengths. The company won FDA clearance for the devices in 2019.
“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,” president and CEO Lisa Dunlea said in a news release.
XableCath Crossing devices have been used to cross challenge lesions in the peripheral vasculature. They have also been used to successfully cross recalcitrant chronic venous obstructions, including in some of the most challenging venous procedures, crossing in-stent restenosis.
“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 that the existing crossing devices,” Dunlea said. “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.”
“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,” Johannes Dahm, professor of medicine-cardiology-angiology in Germany, said. “Our center conducted the first-in-man studies using the device to recanalize very challenging lesions in patients with no other interventional options and critical limb ischemia. I am excited to bring it back more fully into my lab to help me and my patients.”