Cardiovascular Systems (CSI) has announced two new partnerships broadening the company’s product portfolio. According to a company release, CSI is now the exclusive US distributor of OrbusNeich balloon products. Additionally, the company has signed an original equipment manufacturer agreement with Integer Holdings Corporation for CSI-branded ZILIENT guidewires.
Scott Ward, CSI’s chairman, president and chief executive officer, says, “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.”
As the exclusive distributor of OrbusNeich balloon products in the USA, 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 1mm coronary balloon to be available in the USA. 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.
“Entering the USA 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 USA. 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,” says Scott Addonizio, senior vice president and chief operating officer, OrbusNeich.
In addition to its new partnership with OrbusNeich, 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, 300cm length
- .018” diameter with 4, 6, 12, and 30 gram tip stiffness, 300cm 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.
