Redwood City, Calif.-based Avinger said the newly launched Pantheris device features a single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. The system is designed to treat blocked peripheral blood vessels, using its Lumivascular optical coherence tomography technology, the company added.
“We are very pleased to deliver an enhanced device that will help Dr. Schwartzberg, and other physicians like him, produce better outcomes for patients. Our first US cases confirm many of the design changes incorporated into the next-generation Pantheris have improved performance and durability of the technology. Gaining experience across multiple users in the United States, different physician specialties, and a variety of lesion characteristics further substantiates the results generated with the next-generation device in Europe over the past few months,” prez & CEO Jeff Soinski said in a press release.
The new system has been used to treat over 40 patients in the US at 13 sites, and adds to 30 initial cases performed in Germany earlier this year, Avinger said.
“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 which indiscriminately engage both normal and abnormal tissue, potentially creating harm. 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,” Dr. Glen Schwartzberg, who was the first to use the next-gen device, said in a prepared statement.
Earlier this month, Avinger said it launched a post-market study comparing optical coherence tomography to intravascular ultrasound as used during interventions in the peripheral arteries.