Cardiovascular Systems Unveils New Data from CONFIRM Study Series at the New Cardiovascular Horizons Conference
June 06 2013 - 10:00AM
Business Wire
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), unveiled new
data from its CONFIRM study series in three poster presentations at
the 2013 New Cardiovascular Horizons (NCVH) conference in New
Orleans.
The CONFIRM study series evaluated the use of CSI’s orbital
atherectomy system as a treatment for peripheral arterial disease
(PAD)—in above- and below-the-knee lesions—in a real world
population of patients (with no exclusions).
Eighty-one percent of the lesions treated had severe or moderate
calcification—historically considered a difficult patient
population to treat. Patients studied included those suffering from
renal disease, claudication (painful circulatory problems), and/or
critical limb ischemia (CLI) (the worst form of PAD, caused by
chronic inflammation in lower extremities).
CSI posters include:
Pooled Analysis of the CONFIRM Registries: Outcomes in
Patients with Renal Disease Treated for Peripheral Arterial Disease
with Orbital Atherectomy
Dr. Michael Lee, UCLA Medical Center, Los Angeles, shared data
from “Pooled Analysis of the CONFIRM Registries: Outcomes in
Patients with Renal Disease Treated for Peripheral Arterial Disease
with Orbital Atherectomy.” Results show that plaque modification
with CSI’s orbital atherectomy system resulted in similar low
procedural complication rates for patients with renal disease,
compared to those without, despite having more unfavorable baseline
clinical and lesion characteristics.
“Calcified lesions are difficult to treat, and patients with
renal disease could have increased complications after peripheral
intervention. These hard-to-treat patients have historically been
excluded from clinical trials,” said Dr. Lee. “Treatment with CSI’s
orbital atherectomy system resulted in low procedural complication
rates, whether patients suffered from renal disease or
not—indicating that orbital atherectomy is an effective tool for
treating PAD, despite the severity of lesion characteristics.”
Orbital Atherectomy Outcomes of the Critical Limb Ischemia
Patient Population within the CONFIRM Series
“Orbital Atherectomy Outcomes of the Critical Limb Ischemia
Patient Population within the CONFIRM Series,” by Dr. Tony Das,
Cardiology and Interventional Vascular Associates, Dallas, Texas,
was also shared at NCVH. Approximately 44 percent of patients in
the CONFIRM series suffered from CLI, yet the occurrence of
procedural complications was low after treatment with CSI’s orbital
atherectomy system, regardless of arterial calcium burden.
Orbital Atherectomy Outcomes of the Claudicant Patient
Population within the CONFIRM Series
Dr. George Adams, Rex Health Care, Raleigh, N.C., shared data
from “Orbital Atherectomy Outcomes of the Claudicant Patient
Population within the CONFIRM Series.” Claudicant patients
represented 56 percent of patients in the CONFIRM study series, and
of those patients, 81 percent had moderate to severely calcified
lesions. Orbital atherectomy proved to be a safe tool for restoring
blood flow in claudicant patients, regardless of the calcium
severity.
“The majority of claudicant patients suffered from
moderate-to-severe calcification, yet the occurrence of procedural
complications was low after treatment with CSI’s orbital
atherectomy system,” said Dr. Adams. “The favorable results
demonstrate that orbital atherectomy can effectively treat PAD in
claudicant patients, regardless of calcium burden.”
About Peripheral Arterial Disease
As many as 8 million to 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
faster than the rest of the population.
Millions of patients with PAD may benefit from treatment with
orbital atherectomy utilizing the Stealth 360° and Diamondback
360°, 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 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 Orbital Atherectomy System in August
2007. To date, nearly 110,000 of CSI’s devices have been sold to
leading institutions across the United States. CSI has also
completed its ORBIT II Investigational Device Exemption clinical
trial to evaluate the safety and effectiveness of its orbital
technology in treating coronary arteries. The coronary system is
limited by federal law to investigational use and is currently not
commercially available in the United States.
For more information, visit the company’s website at
www.csi360.com.
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