Cardiovascular Systems Features Two-Year ORBIT II Coronary Data & Long-Term Economic Data in Late-Breaking Presentation at SC...
May 07 2015 - 4:00PM
Business Wire
Diamondback 360® Coronary
Orbital Atherectomy System demonstrated:
- High two-year freedom from MACE
rate, including TLR and TVR
- Estimated one-year cost savings of
up to $4,913 per patient
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), featured
two-year data from its ORBIT II study of the company’s Diamondback
360® Coronary Orbital Atherectomy System (OAS), the only U.S. Food
and Drug Administration (FDA) approved Atherectomy Technology
indicated for the treatment of severely calcified lesions, in a
late-breaking presentation at the 2015 Society for Cardiovascular
Angiography and Interventions (SCAI) conference in San Diego.
CSI completed ORBIT II enrollment of 443 patients at 49 U.S.
medical centers in November 2012. The pivotal study evaluated the
safety and efficacy of the company’s orbital atherectomy technology
in treating patients with de novo severely calcified coronary
lesions. ORBIT II was the first IDE study in history to evaluate
this problematic subset of patients. In October 2013, CSI received
PMA approval from the FDA to market its Diamondback 360 Coronary
OAS as a treatment for severely calcified coronary arteries to
facilitate stent delivery.
Dr. Jeffrey Chambers of Metropolitan Heart and Vascular
Institute, Minneapolis, highlighted new data that demonstrated a
high freedom from major adverse cardiac events (MACE) rate,
including target lesion revascularization (TLR) and target vessel
revascularization (TVR), at two years for this difficult-to-treat
patient population.
“ORBIT II two-year data further demonstrates the safety and
efficacy of using CSI’s Diamondback 360 orbital atherectomy system
to treat severely calcified coronary arteries,” said Dr. Chambers.
“We have witnessed impressive clinical and economic benefits of
using this device in a complex patient population that can be
challenging to treat with traditional options. We also know now
that using the coronary OAS device prior to stent treatment in
severely calcified arteries yields durable, long-term results.”
Dr. Chambers presented the following two-year data:
Two-Year Freedom From:
MACE 80.6% MI
(CK-MB >3x ULN)* 90.3% Non Q-wave 91.2%
Q-wave 99.1% TVR/TLR 91.9% TVR 97.1% TLR
93.8% Cardiac Death 95.7%
*Based on reported CK-MB > 3X
ULN
Long-Term Cost EffectivenessLong-term patient outcomes
are critical to understanding rates of hospital readmission when
evaluating cost savings for the treating institutions and overall
healthcare system. The Diamondback 360 Coronary OAS has been
associated with a shorter length of stay for patients when the
device was used to treat severely calcified lesions to facilitate
stent placement compared to treating without the Diamondback 360.
The lower incidence of readmission and shorter length of stay
provide an estimated cost savings of up to $4,913 per patient to
the treating institution at one year following the procedure.
The OAS device offers value with an incremental cost
effectiveness ratio (ICER) of $11,895 per life year gained, which
is well under the $50,000 per quality-adjusted life year (QALY)
threshold, to be considered “high value.”
Said David L. Martin, CSI president and chief executive officer,
“Coronary arterial calcium is traditionally difficult to treat, but
the innovative technology of the Diamondback 360 device provides a
safe and cost-effective way to remove calcium build up in even the
most challenging cases. Our two-year results demonstrate remarkably
improved clinical outcomes and
one-year economic data demonstrated
decreased treatment costs when our orbital atherectomy technology
was employed as the primary treatment prior to stent
deployment.”
About Coronary Artery DiseaseCAD is a life-threatening
condition and a leading cause of death in men and women in the
United States. CAD occurs when a fatty material called plaque
builds up on the walls of arteries that supply blood to the heart.
The plaque buildup causes the arteries to harden and narrow
(atherosclerosis), reducing blood flow. The risk of CAD increases
if a person has one or more of the following: high blood pressure,
abnormal cholesterol levels, diabetes, or family history of early
heart disease. According to the American Heart Association, 16.3
million people in the United States have been diagnosed with CAD,
the most common form of heart disease. Heart disease claims more
than 600,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in nearly 40
percent of patients undergoing a percutaneous coronary intervention
(PCI). Significant calcium contributes to poor outcomes and higher
treatment costs in coronary interventions when traditional
therapies are used, including a significantly higher occurrence of
death and major adverse cardiac events (MACE).
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 and heart 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 peripheral arteries in August 2007.
In October 2013, the company received FDA approval for the use of
the Diamondback Orbital Atherectomy System in coronary arteries. To
date, nearly 200,000 of CSI’s devices have been sold to leading
institutions across the United States. For more information, visit
the company’s website at www.csi360.com.
Product Disclosure
Coronary ProductIndication: The Diamondback 360®
Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital
atherectomy system indicated to facilitate stent delivery in
patients with coronary artery disease (CAD) who are acceptable
candidates for PTCA or stenting due to de novo, severely calcified
coronary artery lesions.
Contraindications: The OAS is contraindicated when the
ViperWire guide wire cannot pass across the coronary lesion or the
target lesion is within a bypass graft or stent. The OAS is
contraindicated when the patient is not an appropriate candidate
for bypass surgery, angioplasty, or atherectomy therapy, or has
angiographic evidence of thrombus, or has only one open vessel, or
has angiographic evidence of significant dissection at the
treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively
tortuous vessels or bifurcations may result in vessel damage; The
OAS was only evaluated in severely calcified lesions, A temporary
pacing lead may be necessary when treating lesions in the right
coronary and circumflex arteries; On-site surgical back-up should
be included as a clinical consideration; Use in patients with an
ejection fraction (EF) of less than 25% has not been evaluated. See
the instructions for use before performing Diamondback 360 Coronary
OAS procedures for detailed information regarding the procedure,
indications, contraindications, warnings, precautions, and
potential adverse events. For further information call CSI at
1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts this device to sale
by or on the order of a physician
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaCRTMatt Sullivan,
612-455-1709matt.sullivan@padillacrt.com
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