Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions

Company partners with OrbusNeich as exclusive U.S. distributor of peripheral and coronary balloons, announces OEM agreement for CSI-branded Zilient guidewires

January 24, 2018 — Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is now the exclusive U.S. distributor of OrbusNeich balloon catheter products. Additionally, the company has signed an original equipment manufacturer (OEM) agreement with Integer Holdings Corp. for CSI-branded Zilient guidewires.

OrbusNeich has 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 U.S. Food and Drug Administration (FDA) clearance for what it calls the first and only 1mm coronary balloon to be available in the United States. Currently, CSI offers both the 1.5-4mm Sapphire II Pro and the 2-4mm Sapphire NC Plus coronary balloons. The company anticipates OrbusNeich’s full balloon product portfolio will become available throughout 2018 and 2019.

CSI has also 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-inch diameter with 4, 6, 12 and 30 gram tip stiffness, 300 cm length; and
• .018-inch 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.

For more information: www.csi360.com