|Freedom from MAE (30-Day)||99.0%||95.7%||90.7%|
|Target Vessel Revascularization (TVR)||99.4%||96.9%||97.9%|
"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.