The study is designed to evaluate the Diamondback 360 Peripheral OAS in treating de novo symptomatic calcified occlusive atherosclerotic lesions in the superficial femoral artery and/or popliteal artery. Credit: Nephron / commons.wikimedia.org.

Cardiovascular Systems (CSI) has enrolled the first participant in the KAIZEN clinical study of its Diamondback 360© Peripheral Orbital Atherectomy System (OAS) to treat calcified plaque in peripheral artery disease (PAD) patients.

Tokyo Bay Urayasu Ichikawa Medical Center Department of Cardiology vice-director Tatsuya Nakama enrolled the first participant in the study.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

The single-arm, prospective, multi-centre KAIZEN clinical study has been designed to assess the efficacy and safety of the Diamondback 360 Peripheral OAS to treat de novo symptomatic calcified occlusive atherosclerotic lesions in the superficial femoral artery and/or popliteal artery.

Up to 100 participants are anticipated to be enrolled at up to 12 study sites.

The Diamondback 360 Peripheral OAS is a catheter-based, single-use, minimally invasive device.

It has been designed to distinguish hard, diseased plaque from healthy, compliant arterial tissue.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

The company stated that the OAS orbiting crown is intended to reduce and change calcified plaque. It also preserves the healthy vessel wall so blood flow can be restored.

CSI stated that the OAS showed efficacy and safety in the US population.

The KAIZEN clinical study is intended to confirm this as well as support regulatory approval in Japan.

Dr Nakama said: “I felt that the Diamondback 360 Peripheral OAS offered both effective treatment and ease of use. I was able to observe significant vessel compliance change, which permitted satisfactory balloon expansion at low pressure.

“Additionally, I felt that minimal distal embolism compared to other devices throughout the procedure was greatly comforting.

“I look forward to further evaluation of the device, but believe it will be seen as a highly welcomed tool in the battle against calcified vessels.”

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
HemoSonics has won the 2025 Marketing Award for its impactful promotion of theQuantra Hemostasis System and leadership in blood management education. See how targeted campaigns, thought leadership content, and hands on clinician training are accelerating Quantra’s market traction and shaping the future of hemostasis testing.

Discover the Impact