Physician Demand Continues to Build for Cardiovascular Systems’ New Coronary
Artery Disease Treatment Technology
*Additional first cases treated at:
*Chandler Regional Medical Center, Chandler, Ariz.
*Deborah Heart and Lung Center, Brown Mills, N.J.
*Florida Hospital, Orlando, Fla.
ST. PAUL, Minn. -- January 23, 2014
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today announced that
physician demand continues to build throughout the United States for its
recently approved Diamondback 360^® Coronary Orbital Atherectomy System (OAS).
The system is the first and only technology approved for the treatment of
severely calcified coronary lesions, and the only new FDA-approved coronary
atherectomy device in more than two decades.
Said Dr. Rohit Bhatheja, Interventional Cardiologist, Florida Hospital,
Orlando, Fla., a physician who recently treated his first case with the
Diamondback 360 Coronary OAS: “Calcium in coronary arteries often goes
undetected and even more, is left untreated because of its complexity. CSI’s
OAS enables physicians to easily treat severely calcified vessels, and allows
for successful stent deployment.”
Significant arterial calcium is present in nearly 40 percent of patients
undergoing a percutaneous coronary intervention, and contributes to poor
outcomes and higher treatment costs in coronary interventions when traditional
therapies are used—including a substantially higher occurrence of death and
major adverse cardiac events.
Commented Dr. Georges Nseir, Invasive Cardiologist, Chandler Regional Medical
Center, Chandler, Ariz., “I am pleased there is a new technology available to
treat the challenges of severely calcified coronary lesions. Clinical data
shows that the Diamondback 360 device can help patients with severe coronary
calcium, a tough-to-treat patient population. I appreciate having a proven and
easy-to-use new technology.”
The Diamondback 360 Coronary OAS uses a patented combination of differential
sanding and centrifugal force to reduce arterial calcium that can cause
complications when treating Coronary Artery Disease (CAD). It has an
eccentrically mounted 1.25-millimeter diamond-coated crown that sands away
calcium in coronary arteries, enabling stent deployment. As the crown rotates
and orbit increases, centrifugal force presses the crown against the lesion,
reducing arterial calcium.
According to Dr. Richard Kovach, Interventional Cardiologist, Deborah Heart
and Lung Center, Brown Mills, N.J.: “CSI’s new Diamondback 360 device offers
my colleagues and me the ability to more appropriately treat severe calcium in
coronary arteries. The device has the ability to facilitate stent deployment
by reducing the calcium in the vessel.”
CSI continues its targeted coronary market launch, and plans to announce
critical one-year data at the ACC conference in March 2014.
About Coronary Arterial Disease
Coronary Artery Disease (CAD) is a life-threatening condition and 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. CAD affects an
estimated 16.3 million people in the United States and is the most common form
of heart disease. Heart disease claims more than 600,000 lives, or 1 in 4
Americans, 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 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 360 Orbital Atherectomy System in August 2007. To date, more than
125,000 of CSI’s devices have been sold to leading institutions across the
United States. In October 2013, the company received FDA approval for the use
of the Diamondback 360 Coronary Orbital Atherectomy System in coronary
arteries. For more information, visit the company’s website at www.csi360.com.
Certain statements in this news release are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995 and are
provided under the protection of the safe harbor for forward-looking
statements provided by that Act. For example, statements in this press release
regarding (i) CSI’s targeted coronary market launch, and (ii) CSI’s plan to
announce critical one-year data at the ACC conference in March 2014, are
These statements involve risks and uncertainties which could cause results to
differ materially from those projected, including but not limited to
dependence on market growth; the reluctance of physicians to accept new
products; the effectiveness of the Diamondback 360 Coronary OAS; actual
clinical trial and study results; the impact of competitive products and
pricing; approval of products for reimbursement and the level of
reimbursement; general economic conditions and other factors detailed from
time to time in CSI’s SEC reports, including its most recent annual report on
Form 10-K and subsequent quarterly reports on Form 10-Q. CSI encourages you to
consider all of these risks, uncertainties and other factors carefully in
evaluating the forward-looking statements contained in this release. As a
result of these matters, changes in facts, assumptions not being realized or
other circumstances, CSI's actual results may differ materially from the
expected results discussed in the forward-looking statements contained in this
release. The forward-looking statements made in this release are made only as
of the date of this release, and CSI undertakes no obligation to update them
to reflect subsequent events or circumstances.
Indications: 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
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 percent has not been
See the instructions for use before performing DIAMONDBACK 360 ^ coronary
orbital atherectomy 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
Cardiovascular Systems, Inc.
Investor Relations, 651-259-2800
Sarah Wozniak, 651-259-1636
Matt Sullivan, 612-455-1709
Marian Briggs, 612-455-1742
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