Cardiovascular Systems Expands Product Portfolio to Support Peripheral, Coronary Interventions

Cardiovascular Systems Inc., a medical device company developing and commercializing interventional treatment systems for patients with peripheral and coronary artery disease, 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 CEO, said, “We intend to build on our 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 U.S. Food and Drug Administration (FDA) clearance for the FIRST AND ONLY 1 mm coronary balloon to be available in the United States. Currently, CSI offers both the 1.5 – 4 mm Sapphire II Pro and the 2 – 4 mm Sapphire NC Plus coronary balloons. The company anticipates OrbusNeich’s full balloon product portfolio will become available throughout 2018 and 2019.
 
“Entering the United States with our coronary and peripheral dilatation catheters has been a major focus and priority for OrbusNeich,” said Scott Addonizio, senior vice president and chief operating officer of 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 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-inch diameter with 4-, 6-, 12-, and 30-gram tip stiffness, 300 cm length
• .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.
 
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.”
 
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, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries.
 
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 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.
 
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes vascular and coronary disease treatment. 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 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.