Cardiovascular Systems Releases Two-Year ORBIT II Coronary Data in Late-Breaking Presentation at 2015 Cardiovascular Research Technologies Conference

  • Diamondback 360® Coronary Orbital Atherectomy System demonstrated:
    • Long term durable outcomes for treating severely calcified lesions
    • Low MACE rates including TLR and TVR

ST. PAUL, Minn., & WASHINGTON--()--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), released two-year data from its ORBIT II study of the company’s Diamondback 360® Coronary Orbital Atherectomy System (OAS) in treating severely calcified lesions in a late-breaking presentation at the at the 2015 Cardiovascular Research Technologies (CRT) conference in Washington, D.C.

“The two-year results of the ORBIT II study continue to demonstrate positive results following treatment with the Diamondback 360 device in treating severely calcified arteries and CSI’s commitment to delivering innovative, durable and cost-effective solutions”

CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. The pivotal study evaluated the safety and efficacy of the company’s orbital atherectomy technology in treating patients with de novo severely calcified coronary lesions. ORBIT II was the first IDE study in history to evaluate this problematic subset of patients. In October 2013, CSI received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary OAS as a treatment for severely calcified coronary arteries.

Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, Minn. highlighted new data that demonstrated low major adverse cardiac events (MACE) rates, including target lesion revascularization (TLR) and target vessel revascularization (TVR), at two years for this difficult-to-treat patient population.

“ORBIT II two-year data reaffirms that CSI’s orbital atherectomy technology is a safe and effective treatment option for severely calcified arteries,” said Dr. Chambers. “Results continue to show the clinical and economic benefits of this device. Furthermore, we now know that using the coronary OAS device prior to stent placement in severely calcified arteries has shown positive long-term results in a complex and problematic patient population.”

Dr. Chambers presented the following two-year data:

MACE (Two Year)*       19.4%
MI (CK-MB >3x ULN)*       9.7%
Non Q-wave 8.8%
Q-wave       0.9%
Target Vessel/Lesion Revascularization 8.1%
TVR 2.9%
TLR       6.2%
Cardiac Death       4.3%

*Based on reported CK-MB > 3X ULN

Long-term Cost Effectiveness
Long-term patient outcomes are critical to understanding rates of hospital readmission when evaluating cost savings for the treating institutions and overall healthcare system. The Diamondback 360 Coronary OAS has been associated with a lower length of stay for patients when the device was used to treat severely calcified lesions compared to treating without the Diamondback 360. A lower incidence of readmission and lower length of stay provide an estimated cost savings in excess of $3,100 per patient to the treating institution.

“The two-year results of the ORBIT II study continue to demonstrate positive results following treatment with the Diamondback 360 device in treating severely calcified arteries and CSI’s commitment to delivering innovative, durable and cost-effective solutions,” said David L. Martin, CSI president and Chief Executive Officer. “Coronary arterial calcium often results in poor clinical outcomes and higher treatment costs, but our two-year results demonstrate significant improvements in both of these areas when our orbital atherectomy technology is employed.”

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 182,000 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.

Product Disclosure

Coronary Product
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 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

Contacts

Cardiovascular Systems, Inc.
Jack Nielsen, 651-202-4919
j.nielsen@csi360.com
or
PadillaCRT
Matt Sullivan, 612-455-1709
matt.sullivan@padillacrt.com

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