Cardiovascular Systems announces launch of Peripheral Orbital Atherectomy System outside the USA


Cardiovascular Systems Inc. (CSI), a medical device company developing and commercialising interventional treatment systems for patients with peripheral and coronary artery disease, has announced that the first patient in Hong Kong has been treated with its Stealth 360 Peripheral Orbital Atherectomy System (OAS). The Hong Kong case is the first commercial use of Peripheral OAS outside of the USA.

Bryan Yan, associate professor, Chinese University of Hong Kong, who treated the first patient in Hong Kong, said, “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 commercialisation 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.”

Scott Ward, chairman, president and CEO of CSI, said, “We are pleased that the first patient treated with OAS in conjunction with our international distribution partner, OrbusNeich, was a success. This positive outcome demonstrates our mutual mission to support physicians in treating patients with peripheral artery disease.”

Scott Addonizio, senior vice president and chief operating officer of OrbusNeich, concluded, “Our experienced sales force is thrilled to bring CSI’s orbital atherectomy technology to Hong Kong. This first procedure occurred only two months after becoming CSI’s international distribution partner. We look forward to introducing CSI’s atherectomy technology to physicians in new markets in the months and years ahead.”

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 USA and Japan.

Additionally, in January 2018, CSI announced that it was the exclusive US distributor for OrbusNeich balloon products. Ultimately, CSI will offer a 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, the first and only 1mm coronary balloon available in the USA.

In November 2016, CSI announced that Medikit, signed an exclusive distribution agreement to sell its coronary and peripheral OAS in Japan.


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