KAIZEN is a single-arm, multi-centre study, designed to evaluate the safety and efficacy of the company’s Diamondback 360 system in treating calcified plaque in patients with peripheral artery disease (PAD)

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CSI starts KAIZEN clinical study in Japan. (Credit: jesse orrico on Unsplash)

US-based medical device company Cardiovascular Systems (CSI) has recruited the first patient in the clinical study of its Diamondback 360 Peripheral Orbital Atherectomy System (OAS).

The study, dubbed KAIZEN, is a single-arm, multi-centre study led by Fukuoka Sanno Hospital cardiovascular medicine centre director and interventional cardiologist Hiroyoshi Yokoi.

It is designed to evaluate the safety and efficacy of the company’s Diamondback 360 system in treating calcified plaque in patients with peripheral artery disease (PAD).

In addition, the KAIZEN clinical trial is expected to support regulatory approval of Diamondback 360 Peripheral OAS in Japan, said CSI.

The first patient was recruited by Tokyo’s Bay Urayasu Ichikawa Medical Centre department of cardiology vice director Tatsuya Nakama.

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.

Dr Yokoi said: “I believe the Diamondback 360 Peripheral OAS has great potential for this underserved patient population, and I look forward to evaluating it in Japan.

“In addition, the high use of imaging by practitioners in Japan will provide greater insight into lesion morphology, and I am confident that this will also help us optimize treatment and safety using OAS.”

According to CSI, PAD occurs due to the accumulation of plaque in the peripheral arteries, and its complexity increases with the more calcification of atherosclerotic plaques.

The Diamondback 360 Peripheral OAS is a minimally invasive, single-use, catheter-based device that can differentiate hard, a diseased plaque from healthy, compliant arterial tissue.

The OAS orbiting crown is said to reduce and modify the calcified plaque while preserving the healthy vessel wall in order to restore blood flow.

The study, which is expected to enrol up to 100 subjects at up to 12 study sites, aims to confirm the safety and efficacy of OAS in Japan, said the medical device company.

CSI chairman, president, and chief executive officer Scott R Ward said: “We look forward to completing KAIZEN and working with the investigators and regulators so that we may offer peripheral OAS therapy to physicians in Japan.”