CSI’s Diamondback 360 OAS Evaluated in KAIZEN Study to Secure Regulatory Approval in Japan

January 11, 2023—Cardiovascular Systems, Inc. (CSI) announced the initiation of the KAIZEN clinical study of the company’s Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment of calcified plaque in patients with peripheral artery disease. The study is intended to support regulatory approval in Japan.

According to the company, KAIZEN is a prospective, single-arm, multicenter study designed to evaluate the safety and efficacy of the Diamondback 360 device in the treatment of de novo symptomatic calcified occlusive atherosclerotic lesions in the superficial femoral artery and/or popliteal artery. The study is expected to enroll up to 100 patients at up to 12 sites.

The safety and efficacy of OAS has been demonstrated in the United States population. The KAIZEN study is intended to confirm this in Japan, noted CSI.

The study is led by Hiroyoshi Yokoi, MD, interventional cardiologist, Director of the Cardiovascular Medicine Center, and Director of Fukuoka Sanno Hospital in Fukuoka, Japan.

“Severely calcified peripheral vessels continue to be a significant challenge for both patient and caregiver, and the need for new treatment devices is greater than ever,” commented Dr. Yokoi in CSI’s press release. “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.”

The first patient in the KAIZEN study was enrolled by Tatsuya Nakama, MD, Vice Director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center in Urayasu, Japan.

Dr. Nakama stated, “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.”