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July 27, 2020

Results From REACH PVI Study of CSI's Transradial Orbital Atherectomy Systems in Lower Extremities Presented

July 27, 2020—Cardiovascular Systems, Inc. announced that procedural data from its REACH PVI study were presented at NCVH 2020: New Cardiovascular Horizons 21st annual conference, held as part of the NCVH digital education series.

REACH PVI is a prospective, observational, single-arm, multicenter postmarket study that enrolled 50 patients at six sites across the United States. The study prospectively evaluated acute clinical outcomes of orbital atherectomy via transradial access for the treatment of peripheral artery disease (PAD) in lower-extremity lesions using CSI’s 5-F extended length Diamondback 360 and Stealth 360 peripheral orbital atherectomy systems (OAS).

According to the company, the results of the REACH PVI study demonstrated a high rate of procedural and treatment success and effectiveness in reducing residual stenosis across all lesions. In the study, 98% of patients achieved both procedural and treatment success, with no reports of serious transradial access-related events. One dissection (Type D-F) was reported. The average time to ambulation reported was 2.7 ± 1.3 hours and lengths of stay averaging 7.2 ± 5.2 hours. Although 68% of lesions were in the superficial femoral artery, other lesion locations included the common femoral artery, popliteal artery, and below the knee.

“It’s a fascinating time for peripheral interventions because the entire case can be done solely with radial artery access," commented Ankur Lodha, MD, national primary investigator for REACH PVI, in the company's announcement. Dr. Lobha, who is an interventional cardiologist, at Cardiovascular Institute of the South in Lafayette, Louisiana, continued, "Radial access can lead to better patient satisfaction and comfort, improved patient safety, and is also beneficial to healthcare economics. CSI is leading the way with their peripheral orbital atherectomy device as it’s the only atherectomy system available that is designed to treat through the radial artery.” Dr. Lobha's NCVH presentation is available online.

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