Lower cumulative procedure costs at one- and
two-years when orbital atherectomy used
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, today announced that a new article
published in the Journal of Medical Economics reviews the two-year
PAD-related health care costs of patients enrolled in the LIBERTY
360° trial.
LIBERTY 360° represents the largest, contemporary real-world
experience with various endovascular strategies across the full
range of Rutherford Class (RC) patients, including those with
critical limb ischemia, the most compromised RC6 patients.
In the article, “Two-year PAD-related health care costs in
patients undergoing lower extremity endovascular revascularization:
results from the LIBERTY 360° trial” by Elizabeth A. Magnuson, et
al., the authors note that among patients with symptomatic lower
extremity PAD undergoing endovascular revascularization, initial
treatment costs and total 2-year costs varied significantly
according to clinical and lesion-level characteristics, as well as
symptom burden.
Said Scott Ward, CSI’s Chairman, President and Chief Executive
Officer, “Data from the LIBERTY 360° study revealed high freedom
from major amputation out to three years (RC2-3, 98.5%; RC4-5,
94.0%; and RC6, 79.9%). And the orbital atherectomy sub analysis of
this data indicated high freedom from major amputation (RC2-3,
100%; RC4-5, 95.3%; and RC6, 88.6%) with no additional amputations
reported after the two-year visit. These data are especially
compelling in the context of cost analyses showing that the durable
patient outcomes from the use of orbital atherectomy resulted in
lower mean cumulative PAD-related costs one- and two-years after
the procedure.”
LIBERTY 360° (OAS RC2-6) 2-Year Costs
Orbital atherectomy (RC2-6; N=503) mean index procedure cost was
$11,729 and by two-years the mean costs were $29,474, numerically
lower than the overall LIBERTY (RC2-6; N=1189) mean two-year cost
of $30,491.
PAD-related costs ($) up to 2
years following the index procedure
All Patients
Any Orbital
Atherectomy
All Patients
Any Orbital
Atherectomy
Index Hospitalization
11,621
(11,189 to 12,081)
11,729
(11,165 to 12,443)
Years 1+2 follow-up
18,870
(17,046 to 20,802)
17,745
(15,113 to 20,835)
Year 1 follow-up
11,741
(10,597 to 12,974)
10,976
(9,344 to 12,741)
Endovascular procedures
7,476
(6,730 to 8,263)
6,911
(5,758 to 8,127)
Endovascular procedures
11,465
(10,321 to 12,688)
10,806
8,944 to 12,916)
Surgical procedures
1,625
1,218 to 2,041)
1,698
(1,096 to 2,384)
Surgical procedures
2,077
(1,616 to 2,569)
1,987
(1,353 to 2,708)
Other PAD hospitalizations
140
(74 to 211)
115
(34 to 231)
Other PAD hospitalizations
193
(113 to 278)
128
(41 to 251)
Outpatient/ chronic care
2,501
(2,011 to 3,000)
2,253
(1,586 to 3,126)
Outpatient/ chronic care
5,134
(4,041 to 6,253)
4,824
(3,272 to 6,791)
Cumulative 1-year
23,362
(22,110 to 24,623)
22,706
(20,998 to 24,627)
Cumulative 2-year
30,491
(28,569 to 32,506)
29,474
(26,655 to 32,665)
Magnuson EA, et al. J Med Econ. 2021 April 18:1
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.
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 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 system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
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:
Indications: The Stealth 360® PAD System and Diamondback
360® PAD System are percutaneous orbital atherectomy systems (OAS)
indicated for use as therapy in patients with occlusive
atherosclerotic disease in peripheral arteries and stenotic
material from artificial arteriovenous dialysis fistulae.
Contraindications: The OAS are contraindicated for use in
coronary arteries, bypass grafts, stents or where thrombus or
dissections are present.
Warnings/Precautions: 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.
See the instructions for use for detailed information regarding
the procedure, indications, contraindications, warnings,
precautions, and potential adverse events. For further information
call CSI at 1-877-274-0901 and/or consult CSI’s website at
www.csi360.com.
Caution: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
The Stealth 360® PAD System and Diamondback 360® PAD System
received FDA 510(k) clearance. The Stealth 360® PAD System is CE
Marked.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210503005494/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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