Cardiovascular Systems (CSI) (NASDAQ: CSII) presented key baseline demographic data from its LIBERTY 360° post-market study in a late-breaking presentation at the 28 th International Symposium on Endovascular Therapy (ISET) in Hollywood, Fla. The study completed its enrollment on Feb. 1, 2016, and will evaluate the acute and long-term clinical and economic outcomes of endovascular device interventions, including CSI's orbital atherectomy system, in treating peripheral arterial disease (PAD).

LIBERTY 360° is a prospective, observational, multi-center post-market study that enrolled over 1,200 patients at 53 sites across the United States, including 500 patients in the Claudicant Rutherford Class 2-3 (R2-3) Arm, 600 in the CLI (critical limb ischemia) Rutherford Class 4-5 (R4-5) Arm and 100 in the CLI Rutherford Class 6 (R6) Arm. The patients will be followed for up to five years, and Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions.

As the first PAD study to specifically include these challenging disease states, LIBERTY 360° will evaluate numerous parameters including procedural success, rate of major adverse events, duplex ultrasound findings, quality of life, six-minute walk test, wound status, economic outcomes and development of plaque burden assessment.

With enrollment now complete, key baseline demographic data was presented at ISET on Tuesday, Feb. 9 by Dr. Jihad Mustapha of Metro Health Hospital in Wyoming, Mich. and Dr. George L. Adams, Rex Healthcare, Raleigh, N.C. Additional authors on the abstract are Dr. William Gray, Main Line Health, Pennsylvania; Dr. Gary Ansel, Riverside Methodist Hospital, Columbus, Ohio; and Dr. Michael Jaff of Massachusetts General Hospital, Boston, who also served as Chair of the LIBERTY 360° publication committee.

Said Dr. Mustapha, "One hundred patients with severe CLI (Rutherford Class 6), the most life-threatening form of PAD, were included in this study. This data may provide unprecedented evidence that these difficult-to-treat patients can be successfully treated. We look forward to sharing this information with the scientific, medical and patient communities."

Dr. Adams added, "LIBERTY 360°, the largest all-comers endovascular-PAD study, includes four core labs to help physicians adequately personalize treatment options."

Key Demographic Analysis Conclusions
  • The interim LIBERTY demographic analysis indicates that the prevalence of Diabetes and Renal Disease increases statistically as the PAD disease state progresses from R2-3 (Claudicant) to R6 (CLI).
  • The data indicates racial disparity in PAD/CLI treatment, which warrants further investigation.

Dr. Jaff concluded, "LIBERTY 360° represents a real-world patient outcome experience with various endovascular strategies across quite severe patient types. Many of these patients would never be included in typical clinical trials. The data from this very large, multi-center, independently adjudicated experience will undoubtedly add to our knowledge base about how to manage patients with advanced, complex peripheral artery disease."

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 peripheral 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, over 235,000 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.

Safe HarborCertain 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 LIBERTY 360° study, including the expected evidence and outcomes from the study, 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, actual study results, 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.

Product DisclosureThe Diamondback 360 ® and Stealth 360 PAD Systems 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.Caution: Federal law (USA) restricts this device to sale by, or on the order of, a physician.

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