First Patients in the Middle East Treated With Diamondback 360 Coronary Orbital Atherectomy System

Cardiovascular Systems Inc. (CSI), a medical device company developing and commercializing interventional treatment systems for patients with peripheral and coronary artery disease, announced 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, CEO and head of the Al Qassimi Hospital Cardiac Center, Sharjah, UAE.
 
Professor Nooryani said, “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.”
 
Scott Ward, chairman, president and CEO of CSI, said, “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.”
 
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.
 
Cardiovascular Systems Inc., based in St. Paul, Minn., is developing and commercializing 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. Food and Drug Administration (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.
 
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.