AngioDynamics has secured CE Mark approval for its innovative Auryon Atherectomy System, a groundbreaking technology for treating Peripheral Artery Disease (PAD). This approval marks a significant milestone for the company and offers new treatment options for PAD patients in Europe.
The Auryon System utilizes groundbreaking solid-state laser technology to remove plaque and blockages in arteries, revolutionizing the treatment of PAD. It effectively addresses lesions of varying types, lengths, and locations, minimizing damage to vessel walls and offering a safe and targeted approach.
Laura Piccinini, AngioDynamics Senior Vice President and General Manager, indicated that the CE Mark approval of the Auryon System represents a significant achievement in their mission to provide effective solutions for healthcare professionals treating PAD.
The Auryon System has a proven track record, having treated over 50,000 patients in the United States after receiving FDA clearance in 2020. The CE Mark approval expands access to this advanced laser platform for PAD patients in the European Union, addressing a global market worth $1.1 billion.
Clinical studies have demonstrated the efficacy of the Auryon Atherectomy System in treating a wide range of lesions, from soft plaque to calcified blockages. Its 355nm wavelength laser platform generates short UV laser pulses, targeting biological reactions to effectively remove plaque while minimizing the risk of perforation and preserving the ability to vaporize lesions.
The Auryon Atherectomy System includes aspiration and off-set capabilities, allowing clinicians to address embolization risks and treat all lesion types, including In-Stent Restenosis (ISR) and Critical Limb Ischemia (CLI).
Nicolas Shammas, MD, published a prospective study examining the use of the Auryon laser system in patients with CLI. The study found that the system effectively reduced residual stenosis in most patients, eliminating the need for target lesion revascularization. The PATHFINDER registry further supports these findings, demonstrating significant improvement in blood flow and the absence of flow-limiting dissections.
AngioDynamics’ commitment to innovation in treating PAD is evident in the Auryon Atherectomy System. This approval expands the company’s reach and provides PAD patients access to cutting-edge technology that offers safe and effective treatment options.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
