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Prominent Physicians to Present New Arterial Calcification Research at 2013 TCT Conference



  Prominent Physicians to Present New Arterial Calcification Research at 2013
  TCT Conference

   Building on PAD Expertise, CSI Secures Coronary Approval; TCT Events to
          Address Complexities of Calcification in both PAD and CAD

Business Wire

ST. PAUL, Minn. -- October 23, 2013

Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), announced today that new
data about the treatment of arterial calcification will be unveiled at the
2013 Transcatheter Cardiovascular Therapeutics (TCT) conference in San
Francisco, Oct. 27–Nov. 1, 2013. Arterial calcium is a common occurrence for
the millions of patients suffering from peripheral artery disease (PAD) and
coronary artery disease (CAD), and it can lead to significant complications.
Calcified plaque is estimated to be present in approximately 65 percent of the
population treated annually for PAD.

CSI’s Peripheral Orbital Atherectomy System (OAS) contains a proprietary
platform technology that provides clinical benefits, and its centrifugal force
allows for treatment of a broad range of arterial vessel diameters. It also
offers differential sanding with a unique orbital crown, which reduces
complications. Visitors to CSI’s booth at TCT can view interactive, virtual
demonstrations of the device and learn how to treat atherosclerotic tissues,
including calcified plaque. The Stealth 360^® now features an all new prime
button that allows for quick flushing, an added measure of control for
physicians.

CSI Secures Coronary Approval
The company’s TCT’s events follow CSI’s recent coronary approval. On Oct. 21,
CSI received Premarket Application (PMA) approval from the U.S. Food and Drug
Administration (FDA) to market its Diamondback 360^® Coronary Orbital
Atherectomy System as a treatment for severely calcified coronary arteries.

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.

CSI began a controlled commercial launch of its Diamondback 360 Coronary OAS
immediately following FDA approval.

 
Peripheral Presentations at TCT
 
Oral Presentation
 
         Dr. Lawrence Garcia, St. Elizabeth’s Medical Center, Boston, will
WHAT:    present “The Data-Driven Role of Atherectomy in SFA Disease Today and
         Tomorrow: LIBERTY 360 and the JET Registry.”
 
WHEN:    Sunday, Oct. 27, 1:12 p.m.
 
WHERE:   Moscone Center West
         Room 2020
         800 Howard Street
         San Francisco, CA 94103
 
Poster Presentations
 
         “Sub-analysis of the CONFIRM Registries: Outcomes in Claudicant
WHAT:    Patients Treated for Peripheral Arterial Disease with Orbital
         Atherectomy,” presented by Dr. George L. Adams
 
         “Pooled Analysis of the CONFIRM Registries: Outcomes in Elderly
         Patients Treated with Orbital Atherectomy for Peripheral Arterial
         Disease,” presented by Dr. Michael S. Lee
 
         “Pooled Analysis of the CONFIRM Registries: Outcomes in Critical Limb
         Ischemia Patients Treated for Peripheral Arterial Disease with
         Orbital Atherectomy,” presented by Dr. Tony Das
 
         “Pedal Arch Reconstruction Utilizing Orbital Atherectomy Challenging
         Case,” presented by Dr. Arthur C. Lee
 
WHEN:    Tuesday, Oct. 29, 3:30–5:30 p.m.
 
 
WHERE:   Moscone Center
         West Building 1^st floor
         800 Howard Street
         San Francisco, CA 94103
          

 
Coronary Presentations at TCT
 
Oral Presentation
 
         Dr. Jeffrey Chambers, Mercy Hospital, Coon Rapids, Minn., will
WHAT:    present “Evaluation of Utility and Efficacy of Orbital Atherectomy to
         Treat Severely Calcified Lesions: ORBIT II.”
 
WHEN:    Monday, Oct. 28, 5:56 p.m.
 
WHERE:   Moscone Center West
         Room 2007
         800 Howard Street
         San Francisco, CA 94103
 
Poster Presentations
 
         “Predictors of Stent Expansion After Drug-eluting Stents: An
WHAT:    ADAPT-DES IVUS Substudy,” presented by Dr. Nobuaki Kobayashi, Dr.
         Gary S. Mintz and Dr. Gregg W. Stone
          
         “Relationship Between Renal Function and Lesion Morphology: An
         ADAPT-DES VH-IVUS Substudy,” presented by Dr. Shigeo Saito, Dr. Gary
         S. Mintz and Dr. Gregg W. Stone
 
WHEN:    Tuesday, Oct. 29, 3:30–5:30 p.m.
 
WHERE:   Moscone Center
         West Building 1^st floor
         800 Howard Street
         San Francisco, CA 94103
          

 
Sponsored Evening Sessions at TCT
 
Two evening sessions at TCT will explore topics regarding coronary
calcification and below-the-knee (BTK) intervention. These symposia are
sponsored by Cardiovascular Research Foundation, supported through an
educational grant from Cardiovascular Systems, Inc.
 
                      “Coronary Calcification: Between a Rock and a Hard
WHAT:                 Place,” chaired by Dr. Gregg W. Stone and Dr. Maurice
                      Buchbinder
 
WHEN:                 Tuesday, Oct. 29, 7–8:30 p.m.
 
WHERE:                Moscone Center West
                      Room 2014–2018
                      800 Howard Street
                      San Francisco, CA 94103
 
                      “A Deep Dive on BTK Intervention: Strategy Technique and
WHAT:                 Emerging Therapeutic Devices,” chaired by Dr. Juan F.
                      Granada, Dr. William A. Gray, Dr. Barry T. Katzen and
                      Dr. Jihad A. Mustapha
 
WHEN:                 Thursday, Oct. 31, 7–8:30 p.m.
 
WHERE:                Moscone Center West
                      Room 2002–2006
                      800 Howard Street
                      San Francisco, CA 94103
                       

CSI Booth at TCT: Oct. 27–31

Visit CSI at booth #529, 5–7 p.m., Tuesday, Oct. 29, and 9 a.m.–5 p.m.,
Wednesday, Oct. 30, and Thursday, Oct. 31, to meet the company’s calcium
experts and learn more about CSI’s orbital technology.

About Peripheral Arterial Disease
PAD is a life-threatening condition where a fatty material called plaque
builds up on the inside walls of the blood vessels that carry blood from the
heart to legs and arms. The plaque buildup causes the arteries to harden and
narrow (atherosclerosis), reducing blood flow to the legs. The risk of PAD
increases if a person has one or several of the following: high blood
pressure, abnormal cholesterol levels, diabetes, or personal history of heart
disease, heart attack or stroke. PAD affects an estimated 8-12 million people
in the United States. The disease prevalence increases with age and 12-20
percent of Americans age 65 and older suffer from PAD symptoms. As the U.S.
population ages, the prevalence range could reach 16 million in those age 65
and older and 19 million overall by 2050.

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.

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
System is a platform technology for the treatment of calcified fibrotic plaque
in arterial vessels. In August 2007, the FDA originally granted CSI’s first
OAS device 510(k) clearance for the use of the Diamondback Peripheral Orbital
Atherectomy System. To date, nearly 120,000 of CSI’s peripheral devices have
been sold to leading institutions across the United States CSI has recently
been granted approval by the FDA for the Diamondback 360^® Coronary OAS,
another revolutionary step toward treating calcified lesions. Cardiovascular
Systems, Inc.

For more information, visit the company’s website at www.csi360.com.

Coronary 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.

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
Janey Kiryluik, 612-455-1724
janey.kiryluik@padillacrt.com
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