Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.

“As physicians, we have continued to advance techniques and expand access to interventional cardiology procedures. As a result, the patients we are treating today have become increasingly complex, with more challenging lesions and anatomy, and with more difficult clinical indications”

OrbusNeich’s 1.0mm Sapphire II PRO, the first and only 1.0mm coronary balloon available in the U.S., offers industry-leading entry and crossing profiles and is precision engineered for crossing and treating extremely tight and complex lesions.

In January, CSI announced it is the exclusive U.S. distributor of OrbusNeich balloon products. OrbusNeich is a globally recognized corporation with established balloon technologies in both percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

“As physicians, we have continued to advance techniques and expand access to interventional cardiology procedures. As a result, the patients we are treating today have become increasingly complex, with more challenging lesions and anatomy, and with more difficult clinical indications,” according to David E. Kandzari, M.D., Director of Interventional Cardiology and Chief Scientific Officer, Piedmont Heart Institute, Atlanta, GA, and principal investigator for the Sapphire II PRO U.S. Clinical Study. “With its exceptionally low profile and deliverability, the Sapphire II PRO is an important new tool to enable us to better treat the patients we serve.”

Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “Offering the Sapphire II PRO 1.0mm coronary balloon—the smallest, FDA-cleared coronary balloon on the market—is critical for physicians treating highly complex coronary lesions. As the market leader in coronary atherectomy, the 1.0mm balloon complements our orbital atherectomy system as we continue providing advanced solutions for treating the complex and high-risk indicated patient.”

At launch, CSI will offer both the 1.0-4.0mm Sapphire II PRO and the 2.0-4.0mm Sapphire® NC Plus non-compliant coronary balloons on a limited basis. The company anticipates that OrbusNeich’s full balloon product portfolio will become available in the U.S. throughout 2018 and 2019.

About OrbusNeich

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, Florida, USA; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to physicians in more than 60 countries.