ST. PAUL, Minn.--(BUSINESS WIRE)--Cardiovascular Systems (CSI) (NASDAQ: CSII) presented key baseline demographic data from its LIBERTY 360° post-market study in a late-breaking presentation at the 28th 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 Harbor
Certain 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 Disclosure
The 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.