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Cardiovascular Systems Expands Product Portfolio to Further Support Peripheral and Coronary Interventions

ST. PAUL, Minn.--(BUSINESS WIRE)--

Cardiovascular Systems, Inc. (CSI) (CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced two new partnerships broadening the company’s product portfolio. CSI is now the exclusive U.S. distributor of OrbusNeich balloon products. Additionally, the company has signed an original equipment manufacturer (OEM) agreement with Integer Holdings Corporation for CSI-branded ZILIENT™ guidewires.

Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We intend to build on our market-leading position in atherectomy to become the partner of choice for peripheral and coronary interventions by offering complementary products that support our core capabilities. Adding high-quality balloons and guidewires to our portfolio is an important first step as we begin to leverage our commercial footprint and enhance CSI’s value to physicians treating patients with peripheral or coronary artery disease.”

OrbusNeich Balloons
OrbusNeich is a globally recognized corporation with established balloon technologies in both percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA) outside the United States. As the exclusive distributor of OrbusNeich balloon products in the United States, CSI will ultimately offer their full line of semi-compliant, non-compliant and specialty balloons for both coronary and peripheral vascular procedures. OrbusNeich PCI balloons include the Sapphire™ II Pro, which is currently on schedule this year to obtain FDA clearance for the FIRST AND ONLY 1.0mm coronary balloon to be available in the United States. Currently, CSI offers both the 1.5-4.0mm Sapphire II Pro and the 2.0-4.0mm Sapphire NC Plus coronary balloons. The company anticipates OrbusNeich’s full balloon product portfolio will become available throughout 2018 and 2019.

Said Scott Addonizio, Senior Vice President and Chief Operating Officer, OrbusNeich, “Entering the United States with our proven coronary and peripheral dilatation catheters has been a major focus and priority for OrbusNeich. This exclusive distribution partnership with CSI provides us with the necessary channel to achieve a dominant presence in the United States. OrbusNeich’s technically advanced balloons coupled with CSI’s highly skilled sales force and management team is the strong strategic partnership needed to achieve our objective. We are excited and confident that through this partnership we will be able to provide physicians with a market-leading portfolio which has already changed the lives of patients and their families around the world.”

ZILIENT Peripheral Guidewires
CSI has contracted with Integer Holdings Corporation to produce CSI-branded ZILIENT guidewires. These guidewires are designed to provide tip resilience and crossability in challenging arterial lesions. CSI is currently offering guidewires to select accounts for use in peripheral interventions in the following sizes/configurations:

  • .014” diameter with 4, 6, 12, and 30 gram tip stiffness, 300 cm length
  • .018” diameter with 4, 6, 12, and 30 gram tip stiffness, 300 cm length

The broad market launch of the CSI-branded ZILIENT peripheral guidewires is expected to begin later in the current fiscal year. CSI anticipates that additional ZILIENT guidewires for coronary interventions and radial peripheral interventions will be available in the future.

Concluded Ward, “We’re increasing the value and expertise that we bring to physicians and patients and expanding our product portfolio in the key areas where CSI excels. While we don’t anticipate a material top-line impact in fiscal 2018, we’re excited about the long-term growth potential from these new partnerships for the company.”

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 Integer Holdings Corporation
Integer Holdings Corporation, is one of the largest medical device outsource (MDO) manufacturers in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solutions markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company's brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at www.integer.net.

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 340,000 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 (i) the future impact of adding balloons and guidewires to CSI’s portfolio; (ii) the specific products to be offered by CSI; (iii) the timing of market launches and availability of balloons and guidewires; and (iv) the financial impact of the addition of these products, 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, regulatory developments; FDA clearances and approvals; 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; our ability to manage our sales force strategy; 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.

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