Avinger stated that it plans to incorporate this next generation version of the device into its ongoing clinical trial program, INSIGHT, an FDA Investigation Device Exemption study.
The US Food and Drug Administration (FDA) has cleared the Pantheris Lumivascular atherectomy system, for the treatment of peripheral artery disease (PAD).
The first-of-its-kind, image-guided atherectomy device is manufactured by Avinger, Inc., and works by merging real-time intervascular imagery with catheters. The device is planned to be offered in 2 versions: standard, and extended length nosecone to the initial US launch sites. Currently, PAD is a growing condition and is expected to affect more than 21 million people in the United States by 2020.
“We are excited to introduce the next generation Pantheris to our network of physicians here in the United States,” Jeff Soinski, Avinger’s president and CEO, said in a statement. “After extensive testing by our R&D and operations teams, physician design validation, and successful initial case experience in Europe across a variety of different lesion types, we believe this next generation device will significantly improve the user experience in terms of reliability, efficiency, and ease of use across a spectrum of clinical situations.”
Avinger stated that it plans to incorporate this next generation version of the device into its ongoing clinical trial program, INSIGHT, an FDA Investigation Device Exemption (IDE) study. The multicenter study began enrolling patients in October of last year, with a goal of registering 140 patients. Sean Janzer, MD, of Einstein Medical Center and Glen Schwartzberg, MD, of Baton Rouge General Medical Center are serving as the co-principal investigators of the study.
“For many patients experiencing in-stent restenosis, treatment can result in additional harm and costs when other treatment modalities fail to provide the information and precision needed to see and treat the restenosed lesions,” Janzer said at the time of the study launch. “The Pantheris Lumivascular Atherectomy System has the potential to provide interventionalists with real-time intravascular imaging to more precisely direct plaque excision and avoid interaction with stent struts, leading to better patient outcomes in these often-challenging cases.”
The use of this device during the minimally invasive procedure of atherectomy allows for 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,” according to the company.
Normally, those performing the procedure needed to rely on X-ray and feedback to guide interventions. This new approach should allow for more accuracy in the navigation process, while also mitigating the health care providers’ exposure to ionizing radiation.
This new version of the device was given CE Marking approval in the European Union in December 2017 and has been used since in Germany, according to Avinger.