First Patient Enrolled in Japan for Cardiovascular Systems’ Kaizen Clinical Study

Cardiovascular Systems Inc. has begun the KAIZEN clinical study of its Diamondback 360 Peripheral Orbital Atherectomy System (OAS) for treating calcified plaque in patients with peripheral artery disease (PAD). The study is supporting Japanese regulatory approval.

“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,” CSI Chairman, President and CEO Scott R. Ward said.
 
The first KAIZEN patient was enrolled by Tatsuya Nakama, M.D., vice director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center. “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,” Nakama said. “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.”
 
The Diamondback 360 Peripheral OAS is a minimally invasive, single-use, catheter-based device that is uniquely designed to differentiate between hard, diseased plaque and healthy, compliant arterial tissue. The OAS orbiting crown reduces and modifies calcified plaque while preserving the healthy vessel wall in order to restore blood flow.^2,3,4
 
KAIZEN is a prospective, single-arm, multi-center study led by Hiroyoshi Yokoi, M.D., interventional cardiologist, director of the Cardiovascular Medicine Center and director, Fukuoka Sanno Hospital. The study is designed to evaluate the safety and efficacy of CSI’s Diamondback 360 Peripheral OAS in the treatment of de novo symptomatic calcified occlusive atherosclerotic lesions in the superficial femoral artery and/or popliteal artery. OAS has demonstrated safety and efficacy in the U.S. population and this study is designed to confirm this in Japan. The study is expected to enroll up to 100 subjects at up to 12 study sites.
 
“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,” 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.”
 
PAD is due to accumulation of plaque in the peripheral arteries (atherosclerosis). PAD complexity increases as atherosclerotic plaques become more calcified.¹ Numerous endovascular treatments are available, such as balloons and stents to restore blood flow in blocked arteries. However, calcified lesions are more difficult to treat during these procedures, leading to decreased balloon and stent success and higher procedural complication rates.¹
 
An estimated 8 million to 10 million Japanese residents suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
 
Cardiovascular Systems, based in St. Paul, Minn., develops and commercializes solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. 

References 
¹ Rocha Singh,K.J.,Zeller,T.& Jaff, M.R. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv 83, E212-220,doi:10.1002/ccd.25387(2014).
² Safian, R. D. et al. Orbital atherectomy for infrapopliteal disease: device concept and outcome data for the OASIS trial. Catheter CardiovascInterv73,406-412,doi:10.1002/ccd.21898(2009).
³ Babaev, A. et al. Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study).Vasc Endovascular Surg 49, 188-194,doi:10.1177/1538574415607361(2015).
⁴ Adams, G. L., Khanna, P. K., Staniloae, C. S.,Abraham, J. P. & Sparrow, E. M. Optimal techniques with the Diamondback 360 degrees System achieve effective results for the treatment of peripheral arterial disease. J Cardiovasc Transl Res 4, 220-229,doi:10.1007/s12265-010-9255-x(2011).