Cardiovascular Systems, Inc. announced the company has initiated the KAIZEN clinical study of its Diamondback 360© Peripheral Orbital Atherectomy System (OAS) for the treatment of calcified plaque in patients with peripheral artery disease (PAD). The study is intended to support regulatory approval in Japan. The first KAIZEN patient was enrolled by Tatsuya Nakama, M.D., Vice Director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center.

The Diamondback 360© Peripheral OAS is a minimally invasive, single-use, catheter-based device that is uniquely designed to differentiate between hard, diseased plaque and healthy, compliant arterial tissue. The OAS orbiting crown reduces and modifies calcified plaque while preserving the healthy vessel wall in order to restore blood flow. KAIZEN is a prospective, single-arm, multi-center study led by Hiroyoshi Yokoi, M.D., Interventional Cardiologist, Director of the Cardiovascular Medicine Center and Director, Fukuoka Sanno Hospital.

The study is designed to evaluate the safety and efficacy of CSI's Diamondback 360© Peripheral OAS in the treatment of de novo symptomatic calcified occlusive atherosclerotic lesions in the superficial femoral artery and/or popliteal artery. OAS has demonstrated safety and efficacy in the U.S. population and this study is designed to confirm this in Japan. The study is expected to enroll up to 100 subjects at up to 12 study sites.

PAD is due to accumulation of plaque in the peripheral arteries (atherosclerosis). PAD complexity increases as atherosclerotic plaques become more calcified.1 Numerous endovascular treatments are available, such as balloons and stents to restore blood flow in blocked arteries. However, calcified lesions are more difficult to treat during these procedures, leading to decreased balloon and stent success and higher procedural complication rates.