CSI Expands Product Portfolio for Coronary and Peripheral Interventions

January 18, 2018—Cardiovascular Systems, Inc. (CSI) announced two new partnerships that broaden the company’s product portfolio. CSI has become the exclusive United States distributor of OrbusNeich's coronary and peripheral balloon products. Additionally, the company has signed an original equipment manufacturer agreement with Integer Holdings Corporation for CSI-branded Zilient guidewires.

According to CSI, OrbusNeich's percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty devices have an established commercial presence outside the United States. As the exclusive distributor of OrbusNeich balloon products in the United States, CSI will ultimately offer OrbusNeich's full line of semicompliant, noncompliant, and specialty balloons for both coronary and peripheral procedures.

OrbusNeich PCI balloons include the Sapphire II Pro 1-mm coronary balloon, which is currently on schedule to obtain US Food and Drug Administration clearance in 2018. Currently, CSI offers both the 1.5–4-mm Sapphire II Pro and the 2–4-mm Sapphire NC Plus coronary balloons. CSI anticipates OrbusNeich’s full balloon product portfolio will become available throughout 2018 and 2019.

CSI has contracted with Integer to produce the Zilient guidewires, which 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: 0.014-inch diameter with 4-, 6-, 12-, and 30-g tip stiffness and 300-cm length; and 0.018-inch diameter with 4-, 6-, 12-, and 30-g tip stiffness and 300-cm length.

The broad market launch of the CSI-branded Zilient devices is expected to begin later in the current fiscal year. Additional Zilient guidewires for radial peripheral interventions and coronary interventions are expected to be available in the future, advised CSI.