June 28, 2018
First Patients Treated With Avinger's Next-Generation Pantheris System in the United States
June 26, 2018—Avinger, Inc. announced the introduction of its next-generation Pantheris Lumivascular image-guided atherectomy system for the treatment of peripheral artery disease. The initial procedures, conducted in more than 40 patients at 13 sites in the United States, provide the foundation for an expanded market launch.
In May, the company announced 510(k) clearance from the US Food and Drug Administration for the Pantheris system. Avinger received European CE Mark approval for the system in December 2017, which was followed by the first 30 cases completed in Germany earlier this year.
According to the company, the Pantheris design includes a simplified single-balloon system for cutter apposition and blood flow management, a stiffer shaft for increased pushability, a more robust nosecone with the option for more tissue storage capacity, and an enhanced cutter design.
Glen Schwartzberg, MD, a vascular surgeon at Baton Rouge General in Baton Rouge, Louisiana, was the first physician in the United States to use both versions of the device, the Pantheris A400 standard nosecone and Pantheris A400X extended nosecone, in separate cases.
In Avinger's announcement, Dr. Schwartzberg commented, “I am very excited about the outcomes for patients that the next-generation Pantheris has helped me achieve in my initial 10 cases. Since the infancy of this technology, I have always thought onboard image-guided atherectomy represented the future of endovascular intervention for many types of disease because of its ability to target specific pathology as opposed to other atherectomy devices that indiscriminately engage both normal and abnormal tissue, potentially creating harm."
Dr. Schwartzberg continued, "While still early in our experience with the device, the new design features have already expanded the applicability of Pantheris to a wider variety of lesion types and I have observed a marked improvement in cutting efficiency and ease of use. I use Pantheris as my front-line therapy due to its safety profile with the reduction of radiation and contrast delivery to the patient and my firm belief that this approach will generate better long-term results for patients. The data from the VISION trial with the first-generation Pantheris demonstrated the longer-term efficacy and safety of this therapy, and the body of evidence should only grow from here.”