CSII Cardiovascular Systems Inc

• Information shared about the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Micro Crown includes:
  • 85% Procedural Success
  • 85% 30-day Freedom from MACE Rate

Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), today released 30-day results from its Coronary Orbital Atherectomy System Study (COAST) in a late-breaking presentation at the 2016 Cardiovascular Research Technologies (CRT) conference in Washington, D.C.

The COAST study is CSI’s prospective, single-arm, multi-center, global IDE trial to evaluate the safety and efficacy of the company’s next-generation Micro Crown orbital atherectomy technology in treating patients with severely calcified coronary lesions. It follows the ORBIT II pivotal trial of the company’s Diamondback 360® Coronary OAS Classic Crown, which received PMA approval from the U.S. Food and Drug Administration (FDA) in 2013 as a primary treatment for severely calcified coronary arteries when facilitating stent delivery. CSI completed COAST enrollment of 100 patients, including 74 patients at 12 sites in the United States and 26 patients at five sites in Japan, in July 2015.

Dr. Richard A. Shlofmitz of St. Francis Hospital in Roslyn, N.Y., presented the 30-day results including the primary endpoints of procedural success and the freedom from major adverse cardiac events (MACE), including target lesion revascularization (TLR) at 30 days after the procedure. Additional authors on the abstract are: Dr. Shigeru Saito, Shonan Kamakura General Hospital, Kamakura, Japan; Dr. Samin K. Sharma, Mount Sinai Medical Center, N.Y.; and Dr. Gregg Stone, Columbia University Medical Center, N.Y.

COAST 30-day outcomes:

        Procedural Success     85.0% Successful Stent delivery     99.0% Less than 50% residual stenosis     99.0% In-hospital MACE     14.0% Freedom from MACE (30-Day)     85.0% MI (defined as CK-MB >3x ULN)     14.0% Non Q-wave

  12.0%

Q-wave    

   2.0%

Target Vessel/Lesion Revascularization 1.0% TLR    

   1.0%

Cardiac Death     1.0%  

“Adequate modification of severely calcified plaque is an important step to achieve successful stent delivery and expansion,” said Dr. Shlofmitz. “The Diamondback 360° Coronary OAS Micro Crown is designed to engage tight lesions with distal sanding. The results from the COAST IDE Study resulted in 99 percent successful stent delivery and 85 percent freedom from 30-day MACE.”

More information about the study design is available at www.ClinicalTrials.gov; identifier: NCT02132611.

About Coronary Artery Disease (CAD)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% 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. The Stealth 360® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. To date, nearly 235,000 of CSI’s devices have been sold to leading institutions across the United States. The Coronary OAS Micro Crown is limited by federal law to investigational use and is currently not commercially available in the United States.

For more information, visit the company’s website at www.csi360.com.

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Cardiovascular Systems, Inc.Mark Sullivan, 651-900-7077msullivan@csi360.comorPadillaCRTMatt Sullivan, 612-455-1709matt.sullivan@padillacrt.com