FDA clears radial access catheter for atherectomy in peripheral artery disease
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Key takeaways:
- The FDA has cleared a 225 cm radial access catheter for PAD atherectomy.
- Radial access may reduce bleeding risk and the need for femoral closure devices.
AngioDynamics announced its 225 cm radial access catheter for use with the company’s atherectomy system received FDA 510(k) clearance for the treatment of peripheral artery disease.
The catheter (Auryon XL), available in 0.9-mm and 1.5-mm diameters, is designed to expand treatment access points in PAD atherectomy, according to an industry release.
The company stated that use of a general radial access catheter may reduce major bleeding events compared with femoral access and may reduce the need for femoral closure devices.
"Radial access is more than an entry point; it's a transformative expressway to enhanced patient outcomes,” Ankur Lodha, MD, interventional cardiologist at Cardiovascular Institute of the South in Lafayette, Louisiana, said in the release. “With an innovative design and its ease of use, the Auryon XL catheter brings significant advancements to radial procedures as the first non-orbital atherectomy device — setting a new standard for laser atherectomy technology.”
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