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.
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.
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.”