Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announced
today that its CALCIUM 360° Study, the first-of-its kind
prospective, randomized feasibility study, demonstrated the safety
and effectiveness of plaque modification with the Diamondback 360®
PAD System versus the standard of care treatment (balloon
angioplasty) in below-the-knee arteries. This study contributes to
a large and growing body of clinical evidence from 1,200 patients
in nine clinical trials demonstrating that the Diamondback 360° can
predictably treat peripheral arterial disease (PAD) safely and
effectively anywhere in the leg. The Diamondback System, developed
and manufactured by CSI, is a minimally invasive catheter system
that removes hardened plaque to restore blood flow in peripheral
arteries.
Dr. Nicolas Shammas, Trinity Medical Center, Bettendorf, Iowa,
principal investigator of the CALCIUM 360° Study, will present the
acute results in a Wednesday, September 22 poster session (No. 411,
Hall A) from 1 to 3:30 p.m. at the 22nd Annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium in
Washington, D.C., sponsored by the Cardiovascular Research
Foundation.
Two additional studies highlighting the acute safety and
efficacy advantages of the Diamondback 360° will be presented
during the same poster session:
- No. 413: Results of the CONFIRM
Registry of 728 Patients to Establish Real-World Application,
presented by Dr. Raymond Dattilo, principal investigator, St.
Francis Health Center, Topeka, Kansas
- No. 415: Results of the CLEAR
360° Study to Demonstrate Acute Device Safety, presented by Dr.
Cezar Staniloae, principal investigator, NYU Medical Center, New
York
“Creating a new standard of care for patients with PAD starts
with obtaining quality clinical and economic data,” said David L.
Martin, president and chief executive officer of CSI. “Our 360°
Clinical Series represents an armada of reproducible evidence
giving physicians irrefutable proof of the safety and efficacy of
the Diamondback 360° for both above-the-knee and below-the-knee
applications. Our commitment to data-driven results will support
physicians as they make optimal treatment decisions for their
patients with PAD.”
CALCIUM 360° Study Shows Improved Results Over the Current
Standard of Care
The CALCIUM 360° Study randomized 50 patients with critical limb
ischemia under a common protocol to either orbital treatment with
the Diamondback 360° or balloon angioplasty. The primary endpoint
of device success of ≤ 30 percent residual stenosis with no
dissection Type C-F, as determined by operator visualization
angiographically, was met in 92.6 percent of those treated with the
Diamondback 360° and 78.8 percent of those treated with balloon
angioplasty (p < 0.001). Primary treatment in the orbital arm
was followed by low-pressure balloon inflation, while the
physician’s standard protocol for balloon therapy was used in the
alternative arm. Ninety-six percent of the patients had symptoms of
critical limb ischemia (Rutherford classes 4-6), and 94 percent had
moderately or severely calcified lesions. Six- and 12-month
clinical and economic outcomes will be reported as the data becomes
available.
“The Diamondback 360° is particularly effective in changing the
compliance of calcified lesions prior to low-pressure balloon
angioplasty,” said Dr. Shammas. “Traditionally, patients with PAD
have been treated with high-pressure balloon angioplasty, which is
associated with a high rate of dissection and bailout stenting.
With the Diamondback 360°, patients with calcified arteries now
have an ideal option for restoring flow to heal wounds, save legs
and keep patients walking ─ without leaving metal stents in the leg
or having to undergo bypass surgery.”
CONFIRM DIAMONDBACK Registry Demonstrates Safety, Efficacy
Results in Challenging, Real-World Population
The CONFIRM DIAMONDBACK Registry further validates the acute
safety and efficacy of the Diamondback 360° System in a real-world
setting. This prospective, single-arm study enrolled 728 patients
by 84 physicians at 57 centers. All patients considered candidates
for treatment with the Diamondback 360° by the physician were
enrolled consecutively.
“This registry demonstrates the benefits of changing lesion
compliance with the Diamondback 360°, followed by low-pressure
adjunctive balloon angioplasty, if desired, in a very large and
challenging patient cohort,” said Dr. Dattilo. “Data from this
study show that the entire leg can quickly, safely and effectively
be treated by a multitude of physicians with variable experience
and treatment philosophies.” CONFIRM results include a low rate of
procedural events (0.5 percent perforations, 1.2 percent abrupt
closure/no flow and 0.7 percent macro embolization), predictable
plaque removal with a final residual stenosis of 10.5 percent, and
a low bailout stent rate due to dissection (2.2 percent).
CLEAR 360° Study Provides Additional Safety Data
The potential for hemolysis (a breakdown of red blood cells) as
a side effect of orbital atherectomy treatment was evaluated for
its clinical significance in the CLEAR 360° Study. Results of 31
patients at four enrolling centers showed that no clinically
significant hemolysis was found in any subject.
360° Clinical Series of Studies Under Way
CSI’s 360° Clinical Series — including the CONFIRM, CALCIUM 360°
and CLEAR 360° Studies — is designed to demonstrate successful
acute outcomes, durable long-term results and the economic
feasibility of orbital PAD treatment. Other studies under way
include the COMPLIANCE 360° Study to evaluate the effectiveness of
changing lesion compliance with the Diamondback 360° versus
treatment with balloon angioplasty in calcified above-the-knee
arteries and the CONFIRM PREDATOR registry to collect information
on the newly released Diamondback Predator 360™ PAD System.
About the Cardiovascular Research Foundation
The Cardiovascular Research Foundation (CRF) is an independent,
academically focused nonprofit organization dedicated to improving
the survival and quality of life for people with cardiovascular
disease through research and education. Since its inception in
1990, CRF has played a major role in realizing dramatic
improvements in the lives of countless numbers of patients by
establishing the safe use of new technologies and therapies in the
subspecialty of interventional cardiology and endovascular
medicine. For more information, please visit www.crf.org.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a
medical device company focused on developing and commercializing
interventional treatment systems for vascular disease. The
company’s Diamondback 360® and Diamondback Predator 360™ PAD
Systems treat calcified and fibrotic plaque in arterial vessels
throughout the leg in a few minutes of treatment time, and address
many of the limitations associated with existing surgical, catheter
and pharmacological treatment alternatives. As many as 12 million
Americans suffer from peripheral arterial disease (PAD), which is
caused by the accumulation of plaque in peripheral arteries
(commonly the pelvis or leg) reducing blood flow. Symptoms include
leg pain when walking or at rest, and can lead to tissue loss and
eventually limb amputation. In August 2007, the U.S. FDA granted
510(k) clearance for the use of the Diamondback 360° as a therapy
for PAD, and CSI commenced a U.S. product launch in September 2007.
Since then, nearly 30,000 procedures have been performed using the
Diamondback 360° in leading institutions across the United States.
For more information visit the company’s Web site 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 CSI’s
ongoing and future clinical trials; are forward-looking statements.
These statements involve risks and uncertainties which could cause
results to differ materially from those projected, including but
not limited to the potential for unanticipated delays in enrolling
medical centers and patients for clinical trials; the performance
of the Diamondback System 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 Disclosure
The Diamondback 360® PAD System and Diamondback Predator 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.
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