Cardiovascular Systems’ COMPLIANCE 360° Trial Demonstrates Superior Acute Results of the Diamondback 360° over Balloon An...
April 05 2011 - 10:31AM
Business Wire
Acute data from Cardiovascular Systems’ (CSI) (Nasdaq: CSII)
prospective, randomized COMPLIANCE 360° clinical trial was
presented today at the American College of Cardiology’s (ACC) 60th
Scientific Session in New Orleans. The study directly compared the
Diamondback 360® Orbital PAD System versus balloon angioplasty in
treating above-the-knee peripheral arterial disease (PAD), or
blockages in leg arteries.
COMPLIANCE 360° acute results (ACC i2 Poster #507) showed that
the Diamondback 360° Orbital PAD System can achieve far superior
acute results in treating calcium-containing femoropopliteal plaque
by improving lesion compliance through a unique technology known as
differential sanding, without the need for stent placement.
According to Principal Investigator Dr. Raymond Dattilo, St.
Francis Health Center, Topeka, Kan., “The acute data from the
COMPLIANCE 360° trial shows treatment with the Diamondback 360°
leads to better luminal gain, improved lesion compliance (as
reflected in lower balloon pressures post treatment with the
Diamondback 360°) and a marked reduction in bailout stenting. The
Diamondback’s unique orbital mechanism of action with differential
sanding safely removes calcified plaque, reducing the need for
high-pressure balloon angioplasty and stenting.”
David L. Martin, CSI president and chief executive officer
added, “Our commitment to clinical rigor is providing physicians
with the clinical and scientific data needed to support their
treatment decisions and provide optimal patient outcomes. We are
challenging old paradigms by going head-to-head against balloon
therapy, which has previously been considered the standard of care.
We now have acute results from 100 patients in two randomized
studies — COMPLIANCE 360° and CALCIUM 360° — that demonstrate the
unrivaled success of our orbital technology.” The CALCIUM 360°
trial is evaluating the use of Diamondback 360° in treating
calcified lesions below the knee.
Acute data showed treatment with the Diamondback 360° generated
superior outcomes with fewer complications, as follows:
Acute Results from COMPLIANCE 360° Clinical Trial
Diamondback 360°
BalloonAngioplasty
StatisticalSignificance
Met angiographic endpoint 82.4% of
lesions 17.9% of lesions p < 0.0001
Maximum balloon inflation pressure(proxy
for lesion compliance)
3.8 atms 8.9 atms p <
0.0001 Lesions requiring stents 2
(5.9%) 22 (78.6%) p < 0.0001
The COMPLIANCE 360° study enrolled 50 patients at nine U.S.
sites. All patients had been diagnosed with calcium-containing
lesions above the knee with ≥ 70 percent stenosis. Additionally,
they exhibited Rutherford class 2 to 4 symptoms, that is, mild to
severe pain due to blocked arteries. Patients were equally
randomized to two groups: balloon angioplasty alone versus
treatment with the Diamondback 360°, followed by low-pressure
balloon angioplasty (up to 4 atmospheres), if needed, with the
angiographic endpoint of a residual stenosis of ≤ 30 percent
without bailout stenting.
COMPLIANCE 360° patients will have clinical follow up at one,
six and 12 months, along with duplex scanning and Ankle Brachial
Index evaluations, an indication of blood flow through the foot.
Longer term results will be reported as they become available.
COMPLIANCE 360° is part of CSI’s 360° Clinical Series — clinical
studies designed to demonstrate successful acute outcomes, durable
long-term results and the economic feasibility of orbital PAD
treatment. CSI is leading the industry in providing physicians the
clinical and scientific data needed to support their treatment
decisions and provide optimal patient outcomes. The results of the
prospective data accumulated to date confirm the clinical and
economic relevance of CSI’s orbital technology in calcific vessels
large and small, and in previously untreatable disease.
About Peripheral Arterial DiseaseAs 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, which sands 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 37,000 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.
Product DisclosureThe Stealth 360°™, Diamondback 360® and
Diamondback Predator 360® Orbital 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.
Editor’s Note: For background information and images,
please go to
http://pub.psbpr.com/CSI/mediakit-2010/newsroom/Default.aspx.
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