Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announced
data highlighting the advantages of its Diamondback and Predator
360® PAD Systems at the New Cardiovascular Horizons (NCVH) meeting
in New Orleans. Both systems, developed by CSI, are minimally
invasive catheter systems that remove hardened plaque to restore
blood flow in peripheral arteries. Three different studies
representing four e-abstracts confirm the safety and effectiveness,
as well as long-term effectiveness of plaque modification with
orbital technology in arteries above and below the knee. These
studies contribute to a large and growing body of clinical evidence
demonstrating that CSI’s orbital PAD systems can predictably treat
peripheral arterial disease (PAD) in routine and complex cases.
“The data presented at NCVH reinforce the advantages of our
orbital technology, including improved results versus balloon
angioplasty, which was once considered the gold standard,” said
David L. Martin, president and chief executive officer of CSI. “We
now have data from nearly 3,000 patients—more than any other device
of its kind—and we are committed to ongoing clinical and scientific
investigation to support physicians in making treatment decisions
and achieving optimal patient outcomes.”
Six-Month Results of CALCIUM 360° Study Show Improved
OutcomesOver the Current Standard of Care
Dr. Russell Lam, Presbyterian Hospital, Dallas, reported on the
newly released six-month results of the prospective CALCIUM 360°
study. The study randomized 50 patients to either orbital treatment
or balloon angioplasty in patients with Critical Limb Ischemia
(CLI). The key finding was that the Diamondback 360º did not
increase procedural costs, but ischemic burden of the limb was
reduced. Orbital treatment outperformed balloon angioplasty on the
primary endpoint of device success (≤ 30 percent residual stenosis
with no dissection C-F) with 92.6 percent in the orbital arm versus
78.8 percent in the balloon arm meeting the endpoint. In addition,
durability at six months shows potential for improved long term
outcomes.
Six-Month CALCIUM 360º Results Orbital Arm
Balloon Arm Death 0 16% Freedom from
amputation 92% 88% Re-intervention 0 4%
ABI (Baseline / 6 months) .81 / .97 .70 / 1.00
“Endovascular treatment with the Diamondback 360° should be
viewed as a new standard of care in treating patients who are at
risk of losing their limbs,” said Dr. Lam. “By modifying calcified
lesions first, the Diamondback 360º allows use of a lower pressure
adjunctive balloon therapy, and reduces the need for bailout
stenting with improved longer-term patient outcomes.”
Single-Center Results of CALCIUM 360º Study Provide Insight
into Treating CLI Patients
Single-center results from the CALCIUM 360º Study were presented
by Dr. Mustapha, Metro Health Hospital, Grand Rapids, Mich. The
data included 15 patients with 18 lesions with moderately or
severely calcified below-the-knee lesions. Results revealed the
final residual stenosis was less for the Diamondback 360° system,
at 9 percent, than for balloon angioplasty, at 36 percent; a lower
rate of intraprocedural events and bail-out stenting; and six-month
results consistent with the overall study population.
Diamondback 360° Predator Study Delivers Durable 12-Month
Results
Dr. Prakash Makam, Community Hospital, Munster, Ind., evaluated
the long-term durability of plaque modification with the Predator
360º on 46 patients with 57 lesions. Only five patients (8.8
percent) returned for retreatment of the target lesion within 12
months, which is consistent with the OASIS Long-Term Study 12-month
results of 8.9 percent. In addition, this single-center study
showed that the Predator 360º effectively modified lesion
compliance in resistant plaques, demonstrated by the need for only
a low pressure adjunctive balloon (5.3 atmospheres of pressure for
an average of 2.3 minutes). Bail-out stenting was not needed in
this challenging patient population, and only one dissection was
reported.
Single-Center Results of CONFIRM II Predator Registry Yield
Excellent Acute Outcomes
Dr. Gaurav Aggarwala, Utah Cardiology, Layton, Utah, reported on
his single-center results of 35 patients with 65 lesions from the
recently completed CONFIRM II Predator Study, which enrolled a
total of 1,127 patients from 122 centers. Intraprocedural events
included one minor dissection due to balloon angioplasty (1.5
percent), and no occurrences of perforation, slow flow, abrupt
closure or distal embolization. Bail-out stenting due to dissection
occurred in only 1.5 percent of lesions. Patients had lesions
throughout the entire leg (superficial femoral and other proximal
vessels 51 percent, popliteal 38 percent, and tibials 11 percent).
Results included a reduction in stenosis from 89 percent
pre-procedure, to 31 percent post orbital treatment and 7 percent
post adjunctive therapy. Device run time averaged 71 seconds per
patient and was followed by low-pressure balloon angioplasty (mean
2.61 atmospheres of pressure) in 92 percent of patients.
“This data validates that the Predator 360º can safely remove
moderately to severely calcified plaque throughout the entire leg,”
said Dr. Aggarwala. “In my experience, this method of plaque
removal, followed by low-pressure balloon angioplasty, provides
predictable, repeatable results.”
About Peripheral Arterial Disease
As many as 12 million Americans, most over age 65, suffer from
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. 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
the Stealth 360° and Diamondback 360°, minimally invasive catheter
systems developed and manufactured by CSI. These systems use a
diamond-coated crown, attached to a guide wire to sand away plaque
while preserving healthy vessel tissue, or medial integrity — 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 Stealth 360°™,
Diamondback 360® and Diamondback Predator 360® Orbital 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. The U.S. FDA granted 510(k)
clearance for the use of the Diamondback 360° in August 2007 and
for the Stealth 360° in March 2011. To date, more than 46,000 PAD
procedures have been performed using the Diamondback 360° in
leading institutions across the United States.
CSI has also commenced its ORBIT II Investigational Device
Exemption clinical trial to evaluate the safety and effectiveness
of its Diamondback 360° System in treating coronary arteries. The
coronary system is under clinical investigation and is currently
not commercially available in 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 CSI’s ongoing and future clinical trials and the future
benefits of CSI’s orbital PAD systems 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 Systems; 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 DisclosureThe Diamondback 360® PAD System,
Diamondback Predator 360™ PAD System and Stealth 360° Orbital 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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