Cardiovascular Systems Releases Two-Year ORBIT II Coronary Data in Late-Breaking Presentation at 2015 Cardiovascular Research...
February 23 2015 - 4:00PM
Business Wire
- Diamondback 360®
Coronary Orbital Atherectomy System demonstrated:
- Long term durable outcomes for
treating severely calcified lesions
- Low MACE rates including TLR and
TVR
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), released
two-year data from its ORBIT II study of the company’s Diamondback
360® Coronary Orbital Atherectomy System (OAS) in treating severely
calcified lesions in a late-breaking presentation at the at the
2015 Cardiovascular Research Technologies (CRT) conference in
Washington, D.C.
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 U.S. Food and Drug Administration (FDA) to
market its Diamondback 360 Coronary OAS as a treatment for severely
calcified coronary arteries.
Dr. Jeffrey Chambers of Metropolitan Heart and Vascular
Institute, Minneapolis, Minn. highlighted new data that
demonstrated low major adverse cardiac events (MACE) rates,
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 reaffirms that CSI’s orbital atherectomy
technology is a safe and effective treatment option for severely
calcified arteries,” said Dr. Chambers. “Results continue to show
the clinical and economic benefits of this device. Furthermore, we
now know that using the coronary OAS device prior to stent
placement in severely calcified arteries has shown positive
long-term results in a complex and problematic patient
population.”
Dr. Chambers presented the following two-year data:
MACE (Two Year)* 19.4% MI (CK-MB
>3x ULN)* 9.7% Non Q-wave 8.8% Q-wave
0.9% Target Vessel/Lesion Revascularization
8.1% TVR 2.9% TLR 6.2% Cardiac Death
4.3%
*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 lower length of stay for patients when the device
was used to treat severely calcified lesions compared to treating
without the Diamondback 360. A lower incidence of readmission and
lower length of stay provide an estimated cost savings in excess of
$3,100 per patient to the treating institution.
“The two-year results of the ORBIT II study continue to
demonstrate positive results following treatment with the
Diamondback 360 device in treating severely calcified arteries and
CSI’s commitment to delivering innovative, durable and
cost-effective solutions,” said David L. Martin, CSI president and
Chief Executive Officer. “Coronary arterial calcium often results
in poor clinical outcomes and higher treatment costs, but our
two-year results demonstrate significant improvements in both of
these areas when our orbital atherectomy technology is
employed.”
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 182,000 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 ProductIndications: 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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