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 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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version on businesswire.com: http://www.businesswire.com/news/home/20160209005327/en/
Cardiovascular Systems, Inc.Mark Sullivan,
651-900-7077msullivan@csi360.comorPadillaCRTMatt Sullivan,
612-455-1709matt.sullivan@padillacrt.com
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