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New Journal Article Highlights Mechanical Effects of Orbital Atherectomy and Rotational Atherectomy in Treating Heavily Calcified Coronary Lesions

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Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII) today announced that a new article e-published in May 2015 in The Journal of Catheterization and Cardiovascular Intervention highlights the mechanical effect of orbital atherectomy (OA) and rotational atherectomy (RA) in treating heavily calcified coronary lesions.

The article, titled “Optical Coherence Tomography Assessment of the Mechanistic Effects of Rotational and Orbital Atherectomy in Severely Calcified Coronary Lesions,” details results from a study led by Dr. Annapoorna Kini, Professor of Cardiology at the Mount Sinai Hospital and Icahn School of Medicine, and Director of The Cardiac Catheterization Lab at Mount Sinai Hospital.

Said study co-investigator, Samin K. Sharma, MD, Director of Clinical and Interventional Cardiology at The Mount Sinai Medical Center, “We found that using OA versus RA to treat heavily calcified coronary lesions resulted in more significant tissue modification leading to better stent apposition and expansion. This may translate to lower major adverse cardiac event, or MACE, and restenosis rates.”

Dr. Kini’s study sought to assess the mechanical effects of RA and OA on heavily calcified coronary lesions and subsequent stent placement using optical coherence tomography, an established medical imaging technique that uses light to capture three-dimensional images from within arteries and other biological tissue. The retrospective analysis included 20 consecutive patients who were treated with either RA or OA. While small case reports have described the mechanistic effect of RA in calcified coronary lesions, there has been no imaging study to assess the effect of OA on coronary artery architecture and/or compare the effects of two atherectomy devices.

David L. Martin, President and Chief Executive Officer of Cardiovascular Systems, Inc., said, “These results illustrate that OA delivers less stent malaposition and better stent placement and expansion. Similarly, our ORBIT II study results showed successful stent delivery in 98 percent of the procedures, with 96 percent freedom from severe angiographic complications post OA. Two-year ORBIT II results also showed a 94 percent freedom from target lesion revascularization and 81 percent freedom from MACE. We are excited by the growing clinical evidence supporting the procedural success of the Diamondback 360(R) Orbital Atherectomy System in severe coronary calcium.”

About Coronary Artery Disease
CAD is a life-threatening condition and a leading cause of death in men and women in the United States. 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 American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes 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 Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, nearly 200,000 of CSI’s devices have been sold to leading institutions across the United States. For more information, visit the company’s website at www.csi360.com.

Coronary Product Disclosures
Indications: The Diamondback 360(R) 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 before performing Diamondback 360 Coronary OAS procedures 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 this device to sale by or on the order of a physician.

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