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

Friday, January 19, 2018

Cardiovascular Systems, Inc., 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.”