Avinger, Inc., Redwood City, Calif.-based developer of innovative treatments for peripheral artery disease (PAD), announces several physicians have successfully treated more than 40 patients across 13 sites in the U.S., with its next-generation Pantheris image-guided atherectomy system for the treatment of peripheral artery disease (PAD).
The positive initial case outcomes support clinical results achieved in the first 30 cases completed in Germany earlier this year with the system, which has received 510(k) clearance from the U.S. FDA.
The next-generation Pantheris design includes a simplified single balloon system for cutter apposition and blood flow management, a stiffer shaft for increased “push-ability,” a more robust nosecone with the option for more tissue storage capacity, and an enhanced cutter design. These primary feature improvements and other small advancements are intended to augment the performance and reliability of the device, and thus far have resulted in very positive acute outcomes across a variety of lesion types, including heavily calcified disease, chronic total occlusions, and in arteries above and below the knee.
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,” notes Glen Schwartzberg, MD, a vascular surgeon at Baton Rouge General in Louisiana who was the first physician in the U.S. to use both versions of the next-generation device, namely, the Pantheris A400 standard nosecone and Pantheris A400X extended nosecone, in separate cases. He has completed 10 initial cases with the device with positive patient outcomes, he says.
“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,” Schwartzberg says.
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on x-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
For more information, visit www.avinger.com.