Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.

March 1, 2018

Device is the smallest, 510(k) cleared coronary balloon in the
U.S. market

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical
device company developing and commercializing innovative interventional
treatment systems for patients with peripheral and coronary artery
disease, today announced that the U.S. Food and Drug Administration
(FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm
Sapphire® II PRO coronary balloon.

OrbusNeich’s 1.0mm Sapphire II PRO, the first and only 1.0mm coronary
balloon available in the U.S., offers industry-leading entry and
crossing profiles and is precision engineered for crossing and treating
extremely tight and complex lesions.

In January, CSI announced it is the exclusive U.S. distributor of
OrbusNeich balloon products. OrbusNeich is a globally recognized
corporation with established balloon technologies in both percutaneous
coronary intervention (PCI) and percutaneous transluminal angioplasty
(PTA).

“As physicians, we have continued to advance techniques and expand
access to interventional cardiology procedures. As a result, the
patients we are treating today have become increasingly complex, with
more challenging lesions and anatomy, and with more difficult clinical
indications,” according to David E. Kandzari, M.D., Director of
Interventional Cardiology and Chief Scientific Officer, Piedmont Heart
Institute, Atlanta, GA, and principal investigator for the Sapphire II
PRO U.S. Clinical Study. “With its exceptionally low profile and
deliverability, the Sapphire II PRO is an important new tool to enable
us to better treat the patients we serve.”

Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said,
“Offering the Sapphire II PRO 1.0mm coronary balloon—the smallest,
FDA-cleared coronary balloon on the market—is critical for physicians
treating highly complex coronary lesions. As the market leader in
coronary atherectomy, the 1.0mm balloon complements our orbital
atherectomy system as we continue providing advanced solutions for
treating the complex and high-risk indicated patient.”

At launch, CSI will offer both the 1.0-4.0mm Sapphire II PRO and the
2.0-4.0mm Sapphire® NC Plus non-compliant coronary balloons
on a limited basis. The company anticipates that OrbusNeich’s full
balloon product portfolio will become available in the U.S. throughout
2018 and 2019.

About OrbusNeich

OrbusNeich is a global pioneer in the provision of life-changing
vascular solutions and offers an extensive portfolio of products that
set industry benchmarks in vascular intervention. Current products
include the world's first dual therapy stents, the COMBO Plus and COMBO
Dual Therapy Stents, together with stents and balloons marketed under
the names of Azule®, Scoreflex®, Sapphire®
II, Sapphire® II PRO and Sapphire® II NC, as well
as products to treat peripheral artery disease: the Jade® and
Scoreflex® PTA balloons. OrbusNeich is headquartered in Hong
Kong and has operations in Shenzhen, China; Fort Lauderdale, Florida,
USA; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies
medical devices to physicians in more than 60 countries. For more
information, visit www.OrbusNeich.com.

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 the first 510(k) clearance for the use of the
Orbital Atherectomy System in peripheral arteries in August 2007. In
October 2013, the company received FDA approval for the Coronary Orbital
Atherectomy System. To date, over 356,000 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.

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 the benefits of the 1.0mm balloon and
the commercial launch of OrbusNeich’s balloon portfolio in the U.S.,
including the anticipated timing thereof, are forward-looking
statements. These statements involve risks and uncertainties that could
cause results to differ materially from those projected, including, but
not limited to, agreements with third parties to sell their products;
the experience of physicians regarding the effectiveness and reliability
of products sold by CSI; the reluctance of physicians, hospitals and
other organizations to accept new products; the impact of competitive
products and pricing; 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.

US Indications for Use

The Sapphire® II PRO Coronary Dilatation Catheter (1.0-1.25mm
configurations) is indicated for:

  • Balloon pre-dilatation of a stenotic portion of a coronary artery or
    bypass graft stenosis (≥70% stenosis) for the purposes of improving
    myocardial perfusion

The Sapphire® II PRO Coronary Dilatation Catheter (1.5-4.0mm
configurations) is indicated for:

  • Balloon dilatation of the stenotic portion of a coronary artery or
    bypass graft stenosis in patients evidencing coronary ischemia for the
    purpose of improving myocardial perfusion
  • Balloon dilatation of a coronary artery occlusion for the treatment of
    acute myocardial infarction

Contacts

Cardiovascular Systems, Inc.
Jack Nielsen, 651-202-4919
[email protected]
or
Padilla
Matt
Sullivan, 612-455-1709
[email protected]