The Redwood City, Calif.-based company’s Lumivascular tech, including its Pantheris image-guided atherectomy device and Ocelot image-guided chronic total occlusion crossing catheters, use OCT for real-time intravascular imaging during interventions to treat peripheral artery disease.
“As a regular user of diagnostic IVUS to plan treatment and assess results after the delivery of therapy, I have found that having an intravascular view of arterial structures and disease distribution leads to better results for my patients versus if I relied solely on fluoroscopy. Given the correlation between the use of intravascular imaging and clinical outcomes, I am excited to participate in a study that will help expand the incorporation of OCT into the treatment paradigm for peripheral interventions,” study investigator Dr. Edward Pavillard, who enrolled the first cases in the Scan study, said in a press release.
Avinger said it is hopeful that the study will support an initiative to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries, similar to the reimbursement currently provided for the use of intravascular ultrasound during such procedures.
“OCT and IVUS have been well accepted imaging modalities for the diagnosis and treatment of atherosclerotic disease. Published data have shown that intravascular imaging may allow a clinician to more accurately assess vessel size, plaque characteristics, anatomical features, and the adequacy of interventional results. OCT and IVUS imaging also have the potential to limit the amount of radiation to which physicians and cath lab staff are exposed, and also reduce the volume of contrast agent used in the intervention, which can be particularly important in successfully treating patients suffering from impaired kidney function,” study investigator Dr. Luke Sewall of Vascular and Interventional Professionals said in a prepared statement.
The study is slated to enroll 20 subjects with peripheral artery disease at two US centers, and aims to produce at least 115 matched images generated by OCT and IVUS imaging for analysis, the company said.
“This trial represents an important component of our growth strategy. If successful, the results from this study should help support our application for incremental diagnostic reimbursement in procedures incorporating our Lumivascular technology. With diagnostic reimbursement already in place for IVUS imaging in the peripheral arteries, we believe that the reimbursement structure should also support the use of OCT for these types of interventions, especially given the high quality of intravascular imaging provided by OCT,” Avinger prez & CEO Jeff Soinski said in a prepared release.
Last month, Avinger said it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease.