ST. PAUL, Minn.--(BUSINESS WIRE)--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 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. 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 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.