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September 18, 2018
CSI's Stealth 360 Peripheral OAS Launched Outside the United States
September 19, 2018—Cardiovascular Systems, Inc. (CSI) announced the commercial launch of its Stealth 360 peripheral orbital atherectomy system (OAS) outside of the United States, with the first patient treated in Hong Kong by Bryan Yan, MD, Associate Professor, Chinese University of Hong Kong.
The company advised that OrbusNeich is the exclusive international distributor of CSI's coronary and peripheral OAS outside of the United States and Japan under an agreement announced in July 2018. The Stealth 360 peripheral OAS received FDA clearance in 2011 and European CE Mark approval in 2014.
Dr. Yan commented in CSI's announcement, “Patients with severely calcified peripheral arteries can be difficult to treat due to the limitations of traditional angioplasty or stenting. This can also place patients at risk for subsequent complications including repeat interventions and amputation. The commercialization of the Stealth 360 OAS in Hong Kong provides physicians with a minimally invasive treatment option for this complex patient population. I am very satisfied with the procedural outcome for my patient because I was able to avoid implanting a stent in the distal superficial femoral artery and I look forward to continuing treatment of similar patients with this technology.”
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