Cardiovascular Systems enrolls first patient in Japan for Kaizen study

Cardiovascular Systems announced the company has initiated the KAIZEN clinical study of its Diamondback 360 Peripheral Orbital Atherectomy System for the treatment of calcified plaque in patients with peripheral artery disease. 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. 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."