Introduction of Orbital Atherectomy in the Middle East by OrbusNeich® Expands Treatment Options for Patients with Complex Coronary Artery Disease

St. Paul, Minn., January 16, 2019 – 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, announced today that the first patients in the United Arab Emirates (UAE) have been treated with its Diamondback 360® Coronary Orbital Atherectomy System (OAS).

The first UAE patients were treated by Professor Aref Nooryani, Chief Executive Officer and Head of the Al Qassimi Hospital Cardiac Center, Sharjah, UAE.

“Patients with calcific coronary artery disease have poor clinical outcomes. Until today, these patients presented a difficult challenge due to the limitations of the other therapies available to me. CSI’s unique orbital atherectomy technology enables effective modification of calcified lesions. The availability of the Diamondback 360® OAS in the UAE provides physicians, like me, with a minimally-invasive treatment option for a complex patient population.”

Professor Aref Nooryani, Chief Executive Officer and Head of the Al Qassimi Hospital Cardiac Center, Sharjah, UAE

“In six months since we announced our international distribution partnership with OrbusNeich, we have successfully introduced OAS technology in Asia, Europe and the Middle East. Together we are demonstrating that the combination of OrbusNeich’s large international sales channel supported by CSI’s physician training and education will allow us to treat an increasing number of patients suffering from peripheral and coronary artery disease.”

Scott Ward, Chairman, President and Chief Executive Officer of CSI

In July 2018, CSI announced that it had signed an exclusive international distribution agreement with OrbusNeich to sell its coronary and peripheral OAS outside of the United States and Japan.

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s OAS 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 U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. The Stealth 360® Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. Over 400,000 of CSI’s devices have been sold to leading institutions worldwide.

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. For more information, visit