Cardiovascular Systems to Feature ORBIT II Two-Year & Long-Term Economic Data in Late-Breaking Presentation at the SCAI 2015 ...
May 04 2015 - 7:00AM
Business Wire
Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), will feature
two-year results from its ORBIT II trial as well as a long-term
economic analysis of the company’s Diamondback 360® Coronary
Orbital Atherectomy System (OAS) in treating severely calcified
lesions in a late-breaking podium presentation at the Society for
Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific
Sessions in San Diego, Calif., May 6-9.
The pivotal ORBIT II study evaluated the safety and efficacy of
the company’s orbital atherectomy technology, and CSI completed
ORBIT II enrollment of 443 patients at 49 U.S. medical centers in
November 2012. In October 2013, the company 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.
It is estimated that significant arterial calcium is present in
nearly 40 percent of patients treated with interventional
therapies. Calcium can cause complications, including difficult
stent deployment, dissections and, when stents are under expanded,
it can result in the need for a coronary bypass. Since receiving
approval, CSI has continued the controlled commercial launch of its
Diamondback Coronary OAS in the United States and over 6,000
patients have been treated using CSI’s unique technology.
Podium Presentation: ORBIT II Two-Year
Data and Long-Term Economic AnalysisTITLE:
Jeffrey Chambers, MD, Metropolitan Heart and Vascular Institute,
Minneapolis, Minn., will present “Orbital Atherectomy Treatment of
Severely Calcified Coronary Lesions: Two-Year Results of the ORBIT
II Trial and Long-Term Economic Analysis.”
WHEN:Thursday, May 7, 11:45 a.m.
WHERE: Hilton San Diego Bay Front
HotelIndigo ABEFSan Diego, CA
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 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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