Cardiovascular Systems Unveils New Data from CONFIRM Study Series at the New
Cardiovascular Horizons Conference
Subanalysis of CONFIRM Data Highlights Orbital Atherectomy’s Safety in
Treating PAD within Claudicant, CLI, and Renal Disease Patient Populations
*Plaque modification with orbital atherectomy resulted in similar low
procedural complication rates for both patients with and without renal
*Both claudicants and critical limb ischemia patient groups had low rates
of procedural events, regardless of arterial calcium burden
ST. PAUL, Minn. -- June 6, 2013
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
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
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.
Cardiovascular Systems, Inc.
Investor Relations, 651-259-2800
Sarah Wozniak, 651-259-1636
Padilla Speer Beardsley Inc.
Matt Sullivan, 612-455-1709
Dave Folkens, 612-455-1741
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