ASA Monitor April 2024, Vol. 88, 14.
Clearance for catheter for PAD treatment
AngioDynamics has received FDA 510(k) clearance for the Auryon XL Catheter, a 225-cm radial access catheter used with the Auryon Atherectomy System to treat peripheral arterial disease (PAD). PAD affects millions globally, and studies suggest that radial access reduces bleeding and complications compared to femoral access. The large catheter, available in 0.9 mm and 1.5 mm diameters, expands treatment access points, potentially reducing major bleeding incidents by over 70%. Its use eliminates the need for femoral closure devices, supports treating bilateral disease in a single session, and aids faster patient recovery. The atherectomy system for PAD treatment, launched in 2020, has treated various lesions in over 50,000 patients using a 355nm wavelength laser platform enabling the use of short UV laser pulses with targeted biological reactions that are effective in treating PAD, while minimizing the risk of perforation and preserving the ability to vaporize lesions without thermal ablation. The Auryon XL Catheter’s design marks a significant advancement in radial procedures, setting a new standard for laser atherectomy technology. Following FDA clearance, the company initiated a limited market release in January 2024, with a full market release expected in February 2024.
Source: asamonitor.pub/482OIRI
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