CSI Presents Late-Breaking Data at ISET 2013
CONFIRM Study Results Highlight Effectiveness of Orbital Atherectomy in
*CONFIRM is the largest atherectomy dataset ever for PAD—more than 3,100
patients and 4,700 lesions
*Study demonstrates that CSI’s orbital atherectomy system is a safe
treatment for moderate-to-severe plaque and calcified lesions
*Data shows low procedural event rates, improved lesion compliance and less
medial damage—resulting in better long-term durability and preserving
future treatment options
ISET Conference 2013
ST. PAUL, Minn. & MIAMI -- January 23, 2013
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today announced CONFIRM
study series data presented at the 2013 International Symposium on
Endovascular Therapy (ISET). Results show that CSI’s minimally invasive
orbital atherectomy system is an effective treatment for peripheral arterial
disease (PAD). CSI’s technology protects healthy vessel tissue while removing
even the most difficult-to-treat plaque throughout the leg with fewer
complications. The study titled “Procedural Effectiveness of Orbital
Technology in More Than 3,100 Patients with Infra-inguinal Disease: Results
from the CONFIRM Series” was part of a late-breaking presentation at ISET.
“The 3,000-plus real-world patients studied in the CONFIRM series shows that
CSI’s orbital atherectomy system safely and effectively treats
moderate-to-severely calcified lesions,” said presenter Dr. Tony Das,
Cardiology and Interventional Associates, Dallas, Texas. “Orbital atherectomy
led to low bail-out-stent usage, low adverse procedural-event rates and
improved lesion compliance. Additionally, smaller randomized studies point to
improved vessel durability and long-term outcomes—both of which are a first
for atherectomy trials in the peripheral vascular space.”
The prevalence of arterial calcium is vastly underestimated in medicine today.
Calcium, even if it isn’t visible through angiography, is present in about 65
percent of the 2.5 million people diagnosed annually with PAD. Moreover,
calcium leads to poor outcomes and higher treatment costs when traditional
balloon and stent therapies are used—including dissection, vessel wall trauma
and stent fracture.
David L. Martin, CSI president and chief executive officer said: “CONFIRM
reinforces the effectiveness of CSI’s orbital atherectomy in treating 'real
world' patients. The dataset presented today is the largest ever for PAD, and
the CONFIRM study series shows consistent, repeatable results across numerous
interventional physicians. CONFIRM gives physicians confidence that our
technology is an effective and safe PAD treatment for patients.”
The CONFIRM series consisted of three studies that enrolled more than 3,100
patients with 4,700 lesions at 350 sites across the United States from 2009 to
2011. A majority of the lesions had moderate to severe calcium. During the
initial study, physicians treated lesions to maximize the luminal gain, while
the second and third study focused on removing calcium to change vessel
compliance. Each study utilized a progressively smaller crown which reduced
slow flow, vessel closure and spasms.
Data shows that vessel preparation with CSI’s orbital atherectomy system
enables low-pressure adjunctive balloon angioplasty across the studies, with
low procedural events and bail-out stents—which preserve treatment options in
Overall Procedural Outcomes:
Per Lesion CONFIRM I CONFIRM II CONFIRM III
n=1,146 n=1,734 n=1,886
Mean Inflation 5.7 atms 5.4 atms 5.9 atms
Bail-out Stent (due to 3.8% 5.8% 5.2%
Perforation 0.9% 0.6% 0.7%
Distal Embolization n/a 2.2% 2.2%
Vessel Closure 2.1% 1.2% 1.4%
CALCIUM 360° Study 12-Month Results
Also presented at ISET: “Comparison of Orbital Atherectomy Plus Balloon
Angioplasty vs. Balloon Angioplasty Alone in Patients With Critical Limb
Ischemia: Results of the CALCIUM 360 Randomized Pilot Trial,” by Dr. Jonathan
Ellichman, Southern Cardiovascular, Memphis, Tenn. Results demonstrate that
orbital atherectomy treatment with low-pressure percutaneous transluminal
angioplasty (PTA) safely restores flow in patients with critical limb ischemia
and reduces major serious adverse events, compared to PTA alone.
At 12 months, CSI’s technology provided superior outcomes:
Orbital Atherectomy plus PTA alone
Mean Inflation 5.9 atms 9.4 atms
Dissections 3.4% 17.1%
Perforation 0% 2.8%
Distal Embolization 0% 2.8%
Bail-out stenting 6.9% 14.3%
Freedom from major serious adverse 93.3% 57.9%
CALCIUM 360° is a prospective, multi-center randomized study that compared
treatment of below-the-knee lesions with orbital atherectomy versus PTA. All
50 patients had critical limb ischemia (CLI) and calcified lesions. These
conditions are challenging to treat in the small arteries below the knees and
often a precursor to amputation.
CSI Poster Session at ISET
Dr. Barry Weinstock, Mid-Florida Cardiology Specialists, Orlando, Fla., and
Dr. Raymond Dattilo (presenter), St. Francis Health Center, Topeka, Kan.,
presented Cost Consequences of Orbital Atherectomy Plus Angioplasty vs.
Angioplasty Alone for Treatment of Calcified Femoropopliteal Lesions in a
poster session at ISET.
Data shows that orbital atherectomy plus balloon angioplasty has a
significantly lower average stenosis rate, exhibiting compelling short- and
longer-term health and economic data for the use of atherectomy in the
treatment of calcified femoropopliteal lesions.
About Peripheral Arterial Disease
PAD is a life-threatening condition where a fatty material called plaque
builds up on the inside walls of the blood vessels that carry blood from the
heart to legs and arms. The plaque buildup causes the arteries to harden and
narrow (atherosclerosis), reducing blood flow to the legs. The risk of PAD
increases if a person has one or several of the following: high blood
pressure, abnormal cholesterol levels, diabetes, or personal history of heart
disease, heart attack or stroke. PAD affects an estimated 8-12 million people
in the United States. The disease prevalence increases with age and 12-20
percent of Americans age 65 and older suffer from PAD symptoms. As the U.S.
population ages, the prevalence range could reach 16 million in those age 65
and older and 19 million overall by 2050.
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 100,000
of CSI’s devices have been sold to 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 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.
The Stealth 360°^® PAD System, Diamondback 360^® PAD System and 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.
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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