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First Patients in Canada Treated With Cardiovascular Systems, Inc. Diamondback 360® Coronary Orbital Atherectomy System

08/30/21

Introduction of Orbital Atherectomy in Canada Expands Treatment Options for Patients with Complex Coronary Artery Disease

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 that the first patients in Canada have been treated with its Diamondback 360®Coronary Orbital Atherectomy System (OAS).

The first patients in Canada were treated by Sanjog Kalra, MD, Interventional Cardiologist and Cardiac Critical Care Physician at the Peter Munk Cardiac Centre, Toronto General Hospital, part of the University Health Network.

Dr. Kalra said, “Patients with calcific coronary artery disease can have poor clinical outcomes unless optimally treated. Revascularization for these patients requires interventionalists to fully prepare vessels for stenting so that full stent expansion is achieved. We know that perfect stent results lead to the best outcomes.

“Achieving optimal vessel preparation in heavily calcified coronary arteries is amongst my most challenging procedures. CSI’s orbital atherectomy technology enables effective calcium modification to facilitate full stent expansion. In addition, OAS is optimized for efficiency as it allows bi-directional atherectomy in multiple vessel sizes with one device.”

Diamondback combines sanding and pulsatile force to treat a broad range of calcium morphology and lesion types. Orbital atherectomy has demonstrated clinical advantages compared to alternative treatments, including low- rates of procedural complications and target lesion revascularization through 3-years. CSI’s ORBIT II and COAST clinical studies demonstrated that OAS is safe and effective in treating patients with de novo severely calcified coronary lesions. Two real-world studies with approximately 1000 patients have reinforced Diamondback’s safety and high procedural success.

Scott Ward, Chairman, President and Chief Executive Officer of CSI, said, “We are excited to announce the first commercial use of the Diamondback 360® Coronary OAS in Canada. The introduction of this device gives physicians in Canada an effective treatment option for this difficult-to-treat patient population.”

About Coronary Artery Disease (CAD)

CAD is a life-threatening condition and a leading cause of death in men and women globally. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the Centers for Disease Control and Prevention, 18.2 million people in the United States have CAD, the most common form of heart disease. Heart disease claims more than 650,000 lives in the United States each year. According to estimates, significant arterial calcium is present in about 30 percent of patients undergoing a PCI. Significant calcium contributes to poor stent delivery, expansion and wall apposition leading to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).

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 additional information, please visit www.csi360.com and connect on Twitter @csi360.

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 commercial launch of the Diamondback 360® Coronary OAS in Canada and the benefits of this product 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 reluctance of physicians, hospitals and other organizations to accept new products; the effectiveness of these products; the efforts of us and our distribution partners in launching this product; the impact of competitive products and pricing; approval of products for reimbursement and the level of reimbursement; general economic conditions; international trade developments; the ongoing COVID-19 pandemic and the impact and scope thereof on CSI, our distribution partners, the supply chain, and physicians and facilities in Canada, including government actions related to the COVID-19 outbreak, material delays and cancellations of procedures, delayed spending by healthcare providers, and distributor and supply chain disruptions; 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.

Diamondback 360® Coronary Orbital Atherectomy Systems

Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Contraindications: The OAS is contraindicated when the ViperWire® guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.

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.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

The Diamondback 360® Coronary OAS is FDA PMA approved and CE Marked.

Cardiovascular Systems, Inc.
Jack Nielsen
Vice President, Investor Relations & Corporate Communications
(651) 202-4919
j.nielsen@csi360.com

Source: Cardiovascular Systems, Inc.
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