Cardiovascular Systems, Inc. Receives Coronary FDA Approval

  Cardiovascular Systems, Inc. Receives Coronary FDA Approval

  *Diamondback 360^® Coronary Orbital Atherectomy System Approved to Treat
    Severely Calcified Coronary Lesions
  *Controlled Commercial Launch to begin immediately

Business Wire

ST. PAUL, Minn. -- October 22, 2013

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), today announced that it has
received PMA approval from the U.S. Food and Drug Administration (FDA) to
market its Diamondback 360^® Coronary Orbital Atherectomy System (OAS) as a
treatment for severely calcified coronary arteries.

Cardiovascular Systems' revolutionary, new Diamondback 360(R) Coronary Orbital
Atherectomy System, w ...

Cardiovascular Systems' revolutionary, new Diamondback 360(R) Coronary Orbital
Atherectomy System, was recently approved by the U.S. Food and Drug
Administration to treat severely calcified lesions in coronary arteries.
(Photo: Cardiovascular Systems)

“Today is a landmark moment for: patients suffering from calcified coronary
artery disease, their families, our physician operators and everyone at CSI,”
said David L. Martin, President and Chief Executive Officer of Cardiovascular
Systems. “FDA approval of our Diamondback 360 Coronary OAS allows us to bring
to market the first new coronary atherectomy system in more than two decades.”

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
substantially higher occurrence of death and major adverse cardiac events
(MACE). This approval opens up a large, underserved U.S. market opportunity
for CSI, estimated to exceed $1.5 billion annually.

Martin continued, “Severe coronary arterial calcium is an underestimated
problem in medicine, with limited options for treatment. The ORBIT II trial
proved our Diamondback technology is safe and effective in treating this
complex disease. Securing coronary approval is another key milestone in our
mission to provide primary tools for vascular intervention. I’m proud of our
principal physician investigators and scientific teams. Together, with the CSI
team we’re excited to move forward to help a larger physician population treat
these previously underserved patients.”

“Coronary calcium is undertreated in the cardiac cath lab. Having a
user-friendly device available to effectively treat severe coronary calcium
may increase the safety of CAD interventions for this difficult to treat
population, while improving long-term patient prognoses,” said Dr. Gregg
Stone, Professor of Medicine, Columbia University, Director of Cardiovascular
Research and Education Center for Interventional Vascular Therapy New York
Presbyterian Hospital/Columbia University Medical Center and Co-Director of
The Cardiovascular Research Foundation New York, N.Y.

Clinical Data Backs Systems’ Effectiveness

ORBIT II is CSI’s study evaluating the safety and effectiveness of the
company’s orbital atherectomy technology in treating the problematic subset of
patients with severely calcified coronary lesions. It is the first study in
history that sought approval for treating these lesions.

Led by Principal Investigator, Jeffrey Chambers, MD, of Metropolitan Heart and
Vascular Institute, Minneapolis, ORBIT II demonstrated that CSI’s technology
produced clinical outcomes that exceeded the trial’s two primary safety and
efficacy endpoints by a significant margin—within one of the most challenging
patient populations.

At 30 days, ORBIT II results showed patient freedom from MACE was 89.8 percent
and procedural success was 89.1 percent. Excluding in-hospital MACE,
procedural success was 98.6 percent with 97.7 percent of stents successfully
delivered. Moreover, 92.8 percent of patients were free from severe
angiographic complications, and core lab assessed final procedure residual
stenosis was 4.7 percent.

According to Dr. Chambers, “Patients who suffer from severely calcified
coronary lesions are one of the toughest-to-treat populations—and previous
studies have shown these patients have worse outcomes. Thirty-day ORBIT II
results demonstrate that CSI’s orbital atherectomy technology is safe and
effective. With FDA’s approval, physicians now have new technology to treat
patients with severely calcified coronary lesions.”

The Diamondback 360 Coronary OAS uses an electrically driven 1.25 mm
diamond-coated crown to safely reduce calcified lesions in coronary blood
vessels. This ultimately helps enable successful stent deployment, which
facilitates more favorable patient outcomes.

Coronary Rollout Strategy

CSI will begin a controlled commercial launch of its Diamondback 360 Coronary
OAS immediately.

Said Martin, “Our initial coronary rollout will be very targeted. With a
dedicated team of coronary sales specialists, we will focus on a limited
number of the top medical institutions in the United States and continue that
strategy for several quarters. During that time, we'll focus on providing
physicians with a quality experience and on driving adoption in those
accounts. Additionally, we’ll conduct post-market studies to enhance our
product offering and further build our body of clinical data.”

CSI will provide more details on FDA approval and its launch plans for the
Diamondback 360 Coronary OAS during its upcoming fiscal 2014 first-quarter
results conference call.

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 16.8 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, nearly
120,000 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.

Safe Harbor

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) the $1.5 billion estimate of the market for a coronary
application and its future growth potential, and (ii) the commercial launch of
the Diamondback 360 Coronary OAS, are forward-looking statements.

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.

Product Disclosure

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
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.

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Contact:

Cardiovascular Systems, Inc.
Investor Relations, 651-259-2800
investorrelations@csi360.com
or
Sarah Wozniak, 651-259-1636
swozniak@csi360.com
or
PadillaCRT:
Matt Sullivan, 612-455-1709
matt.sullivan@padillacrt.com
or
Marian Briggs, 612-455-1742
marian.briggs@padillacrt.com