US-based medical technology company AngioDynamics has secured the US Food and Drug Administration (FDA) 510(k) approval for its Auryon XL Catheter.
Auryon XL is a 225cm radial access catheter intended for use with the company’s Auryon Atherectomy System in the treatment of peripheral arterial disease (PAD).
The Auryon System leverages solid-state laser technology for the treatment of arterial occlusions and is FDA-approved for the treatment of infrainguinal stenoses and occlusions.
It is the first laser atherectomy system that can be used for all types of infrainguinal lesions, including above-the-knee (ATK), below-the-knee (BTK) and In-Stent Restenosis (ISR).
AngioDynamics is offering the Auryon XL Catheter in 0.9mm and 1.5mm diameters, expanding treatment access in atherectomy procedures for PAD.
AngioDynamics Auryon global marketing senior director Kimberly Nelson said: “Since its launch in September 2020, the Auryon Atherectomy System, with its innovative solid-state laser technology, has fundamentally changed patient treatment for PAD and quickly become an essential tool for providers and patients.
“Our entry into the Radial-to-Peripheral (R2P) space with Auryon XL is an important part of our focus on advancing the quality-of-care delivery and it demonstrates our commitment to meeting the unmet needs of patients and atherectomy providers.”
Following the FDA 510(k) approval, AngioDynamics started a limited market release of the Auryon XL Catheter in the US this month, with plans for a full market release next month.
According to the company, the use of a general radial access catheter may reduce the events of major bleeding than femoral access by more than 70%
In addition, the catheter may eliminate the need for femoral closure devices and allow for the treatment of bilateral disease in a single session.
The Auryon XL Catheter supports improved patient mobility, earlier discharge and faster patient recovery times, said the US medical technology company.
Cardiovascular Institute of the South interventional cardiologist Ankur Lodha said: “Radial access is more than an entry point; it’s a transformative expressway to enhanced patient outcomes.
“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.”
