Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), today released procedural and 30-day results from its LIBERTY 360° study in a late-breaking presentation at the 2016 Amputation Prevention Symposium (AMP) in Chicago.

LIBERTY 360° is a prospective, observational, multi-center clinical study evaluating the clinical and economic outcomes of a variety of endovascular interventions in patients with symptomatic peripheral artery disease (PAD), including critical limb ischemia (CLI), the most severe form of PAD. The study includes all commercially available technologies, including CSI's Diamondback 360 ® Peripheral Orbital Atherectomy System (OAS), to treat claudication and CLI. The company completed enrollment of 1,204 patients across 51 sites in the United States in February 2016.

The LIBERTY study includes patients with various levels of PAD ranked on the Rutherford Classification scale. Included in the analysis are 500 Rutherford Class 2-3 patients, 589 Rutherford Class 4-5 patients and 100 Rutherford Class 6 patients, those with the most severe form of PAD. The study shows that peripheral interventions can be used successfully across all Rutherford classes, including the most challenging Rutherford Class 6. The majority of devices used were balloons and atherectomy, and the Diamondback OAS was the most frequently used atherectomy device, representing approximately 45% of Rutherford Classes 2-5 and over 60% of Rutherford Class 6 interventions.

Dr. George Adams, director of Cardiovascular and Peripheral Vascular Research at Rex Hospital in Raleigh, N.C., presented the 30-day results highlighting the freedom from major adverse events (MAE). Additional authors on the abstract are: Dr. Jihad Mustapha, Metro Health Hospital, Mich.; Dr. William Gray, Lankenau Heart Institute, Penn.; Dr. Gary Ansel, Berger Hospital, Ohio; and Dr. Michael R. Jaff, Massachusetts General Hospital, Mass.

LIBERTY 30-day outcomes:
         
      Rutherford Class
      R2-3       R4-5       R6
Freedom from MAE (30-Day)       99.0%       95.7%       90.7%
Major Amputation       100%       98.8%       95.8%
Target Vessel Revascularization (TVR)       99.4%       96.9%       97.9%
Death       99.6%       99.7%       95.9%
             

Quality of life also improved from baseline across all Rutherford classes.

"The results from the LIBERTY 360° study will provide us with valuable information about the clinical and economic outcomes of atherectomy in PAD patients," said Dr. Adams. "This is the first device study to specifically include patients with a prevalence of calcification across all Rutherford Classes, particularly the most severe form of PAD, Rutherford Class 6. Approximately 50% of lesions showed visible calcification on angiography, and we saw a freedom from MAE rate of 90.7% for Rutherford Class 6 patients at 30 days. Future data will be essential in identifying the most effective ways to treat this challenging patient population."

Dr. Mustapha said, "Procedural complications rarely resulted in post-procedural hospitalization in all Rutherford Classes and, impressively, 78% of Rutherford Class 6 subjects were discharged to their homes." He concluded, "Early findings in this novel, all-comers PAD study suggest that 'watchful waiting' in Rutherford Class 2-3 and 'primary amputation' in Rutherford Class 6 may not be necessary. Percutaneous vascular interventions can be successful in these patient populations as well."

More information about the study design is available at www.ClinicalTrials.gov; identifier: NCT01855412

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.

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, over 260,000 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 future data from the LIBERTY 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 clinical trial and 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.

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