KAIZEN to assess safety and efficacy of peripheral orbital atherectomy to secure regulatory approval in Japan

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the company has initiated the KAIZEN clinical study of its Diamondback 360^© Peripheral Orbital Atherectomy System (OAS) for the treatment of calcified plaque in patients with peripheral artery disease (PAD). 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.”

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.

Dr. Yokoi said, “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. 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

Scott R. Ward, CSI’s Chairman, President and Chief Executive Officer, 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.”

About Peripheral Artery Disease (PAD)

An estimated eight to 10 million Japanese 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.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative 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. For more information, visit www.csi360.com and follow us on LinkedIn and Twitter.

Safe Harbor

Certain statements in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are provided under the protection of the safe harbor for forward-looking statements provided by that Act. For example, statements in this press release regarding the KAIZEN study, regulatory approval of peripheral OAS in Japan, and the commercial introduction of peripheral OAS in Japan, are forward-looking statements. These statements involve risks and uncertainties that could cause results to differ materially from those projected, including, but not limited to, the potential for unanticipated delays in enrolling medical centers and patients for the KAIZEN study; the effectiveness of peripheral OAS in the study; actual clinical results; regulatory developments, clearances and approvals; approval of our products for distribution in Japan; approval of products for reimbursement and the level of reimbursement in Japan; general economic conditions; and other factors detailed from time to time in CSI’s SEC reports, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this release. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, CSI's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this release. The forward-looking statements made in this release are made only as of the date of this release, and CSI undertakes no obligation to update them to reflect subsequent events or circumstances.

CSI^® and Diamondback 360^® are trademarks of Cardiovascular Systems, Inc.

Product Disclosure:

Peripheral Products

The Stealth 360^® PAD System and Diamondback 360^® PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm. See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.

This system is not commercially available Japan.

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).

View source version on businesswire.com: https://www.businesswire.com/news/home/20230111005773/en/