CONFIRM Supports CSI's Diamondback System for Orbital Atherectomy of Infrainguinal Disease

October 10, 2012—At the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas, Tony Das, MD, presented findings from the CONFIRM series during a Late-Breaking Trials session. CONFIRM was conducted to better understand the potential advantages of the use of the Diamondback orbital atherectomy system (OAS) (Cardiovascular Systems Inc. [CSI], St. Paul, MN) in real-world patients with calcified infrainguinal disease.

Dr. Das noted that calcified plaque in peripheral arteries is a significant treatment challenge. Its presence is often underestimated and may contribute to poor endovascular outcomes. Based on clinical experience and study data, patients with calcified plaque have increased risk of many flow-limiting dissections, poor long-term patency, and increased suboptimal stent placement that may lead to stent fractures and difficult-to-treat in-stent restenosis.

The CONFIRM series evaluated the success of orbital plaque modification with three generations of OAS systems from CSI. The series comprises three registries conducted prospectively under a common protocol without inclusion/exclusion criteria (with the exception of treatment to be done per instructions for use). A total of 3,135 patients and 4,766 lesions were treated over the course of nearly 2 years at more than 200 institutions throughout the United States. CONFIRM represents the largest peripheral arterial disease real-world patient data set to-date treated with the OAS.

According to Dr. Das, the CONFIRM series demonstrated consistent, repeatable results across numerous interventional physicians. The procedural effectiveness of orbital technology in calcium-containing infrainguinal disease is exemplified by improved lesion compliance (as reflected in lower balloon pressures), a low rate of procedural events, and reduced stent placement. By its mechanism of action, OAS leads to less medial damage compared to incremental cutters, which may lead to better long-term durability, concluded Dr. Das.