Market Overview

Cardiovascular Systems Presents Liberty 360° Two-Year Outcomes at 2018 Amputation Prevention Symposium

Share:

Late-breaking presentation shows 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 two-year outcomes from its LIBERTY
360° study in a late-breaking presentation at the 2018 Amputation
Prevention Symposium (AMP) in Chicago.

The LIBERTY 360° study is designed to evaluate the acute and long-term
clinical and economic outcomes of peripheral vascular interventions
(PVI) in patients with peripheral artery disease (PAD). With over 1,204
patients enrolled at 51 sites across the United States, it is among the
first PAD studies to investigate patients across the spectrum of
symptomatic PAD (RC 2-6). As an "all comers" study, LIBERTY 360°'s novel
trial design included any endovascular device FDA-cleared for treatment
of PAD.

The two-year study outcomes were presented at AMP by Dr. Jihad A.
Mustapha, MD, FACC, FSCAI, Advanced Cardiac & Vascular Amputation
Prevention Centers Grand Rapids, Michigan. Dr. Mustapha's presentation
highlighted the continued high freedom from major amputation in all
Rutherford Classifications (RC) at two years (RC2-3, 99.1%; RC4-5,
94.5%; and RC6, 79.8%).

Said Dr. Mustapha, "LIBERTY 360° represents as close to a real-world
experience as possible with various endovascular strategies across
Rutherford Classes. Following endovascular intervention, we saw a marked
improvement across all Rutherford Classes at two years, as well as high
freedom from major amputation. In particular, LIBERTY 360° provides
compelling evidence that PVI can lead to amputation free survival even
in RC6 patients, which showed a 79.8% freedom from major amputation
following PVI."

In his presentation, Dr. Mustapha 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, 88.5%).

Said Scott Ward, CSI's Chairman, President and Chief Executive Officer,
"The two-year LIBERTY 360° results continue to show that PVI, including
the use of orbital atherectomy, can lead to amputation free survival for
patients with mild to severe PAD, even 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 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. In March 2017, the company received PMDA approval in Japan for the
Diamondback 360® Coronary OAS Micro Crown and reimbursement
approval effective February 2018. To date, 392,000 of CSI's devices have
been sold to leading institutions across the United States and Japan.
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.

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.

Millions of patients with PAD may benefit from treatment with orbital
atherectomy utilizing the Stealth 360® and Diamondback 360®
Peripheral Orbital Atherectomy Systems, 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. Balloon angioplasty and stents 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.

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-cleared
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 Disclosure
The Stealth 360® PAD System
and Diamondback 360® PAD System 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.

View Comments and Join the Discussion!