Results show significant improvements in
quality of life and high freedom from major amputation
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) a medical
device company developing and commercializing innovative
interventional treatment systems for patients with peripheral and
coronary artery disease, presented 18-month outcomes from its
LIBERTY 360° study at the Cardiovascular Research Technologies
(CRT) 2018 interventional cardiology conference in Washington, D.C.
The study evaluates the acute and long-term clinical and economic
outcomes of endovascular device interventions, including CSI’s
orbital atherectomy system, in treating peripheral artery disease
(PAD).
The 18-month study outcomes were presented at CRT by Dr. William
Gray, interventional cardiologist at Lankenau Heart Institute in
Wynnewood, Pa. Dr. Gray’s presentation highlighted the continued
high freedom from (FF) 18-month Major Adverse Events (MAE) in
Rutherford Classifications (RC) 2-3 (76.9%) and RC4-5 (68.2%). Even
when considering advanced disease in RC6, MAEs are not driven by
major amputation (FF 81.7%). In addition, quality of life improved
significantly from baseline to 18 months in all RC arms of the
LIBERTY study.
Said Dr. Gray, “LIBERTY 360° represents an unrestricted
real-world experience with various endovascular strategies across
different RCs, many of whom would never be included in clinical
trials, especially, RC6 patients. The results we’ve seen in this
novel, all-comers PAD study indicate that endovascular peripheral
vascular intervention is a reasonable treatment option for RC2-3,
RC4-5 and RC6.”
In his presentation, Dr. Gray also noted that an orbital
atherectomy sub analysis of the LIBERTY data indicated high freedom
from major amputation in all Rutherford Classes (RC2-3, 100%;
RC4-5, 95.3%; and RC6, 91.3%). Primary amputation is not necessary
in RC6 as peripheral vascular intervention (PVI) can be successful
in this patient population.
Said Scott Ward, CSI’s Chairman, President and Chief Executive
Officer, “The 18-month LIBERTY 360° results continue to show that
PVI, including the use of orbital atherectomy, can lead to
amputation free survival for patients with claudication or critical
limb ischemia.”
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 the first 510(k) clearance for the use of the
Orbital Atherectomy System in peripheral arteries in August 2007.
In October 2013, the company received FDA approval for the Coronary
Orbital Atherectomy System. To date, over 356,000 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.
About Peripheral Artery Disease (PAD)As many as 18
million Americans, most over age 65, suffer from PAD, which is
caused by the accumulation of plaque in peripheral arteries
reducing blood flow. Symptoms include leg pain when walking or at
rest. Left untreated, PAD can lead to severe pain, immobility,
non-healing wounds and eventually limb amputation. With risk
factors such as diabetes and obesity on the rise, the prevalence of
PAD is growing at double-digit rates. Literature shows that balloon
angioplasty and stents can have significant shortcomings in
treating hard, calcified lesions. Stents are prone to fractures and
high recurrence rates, and treatment of hard, calcified lesions
often leads to vessel damage and suboptimal results. Millions of
patients with PAD may benefit from treatment with orbital
atherectomy utilizing the Diamondback 360® and Stealth
360® Peripheral Orbital Atherectomy Systems, which are
minimally invasive catheter systems developed and manufactured by
CSI. These systems use a diamond-coated crown, attached to an
orbiting shaft, which sands away plaque while preserving healthy
vessel tissue — a critical factor in preventing reoccurrences.
About LIBERTY 360°LIBERTY 360° is a prospective,
observational, multi-center post-market study that enrolled over
1,200 patients at 51 sites across the United States, including 501
patients with claudication (RC2-3), 603 patients with critical limb
ischemia (CLI; RC4-5) and 100 patients with the most severe form of
CLI (Rutherford 6). The study included any endovascular device
FDA-approved for treatment of PAD. Enrollment was completed in
February 2016 and patients will be followed for up to five
years.
LIBERTY 360° is among the first PAD studies to investigate
patients across the spectrum of symptomatic PAD and will assess
numerous parameters including procedural success, rate of major
adverse events, duplex ultrasound findings, quality of life,
six-minute walk test, wound status, and economic outcomes.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20180306005386/en/
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaMatt Sullivan,
612-455-1709matt.sullivan@padillaco.com
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