Cardiovascular Systems Debuts Peripheral Orbital Atherectomy System Outside the U.S.

Cardiovascular Systems Inc. (CSI) 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 United States.
 
Dr. 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 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.”

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.
 
“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,” said Scott Ward, chairman, president and CEO of CSI.

In January 2018, CSI announced that it was the exclusive U.S. 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 1 mm coronary balloon available in the United States.
 
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 November 2016, CSI announced that Medikit Co. Ltd. signed an exclusive distribution agreement to sell its coronary and peripheral OAS in Japan.
 
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes solutions for vascular and coronary disease treatment. The company’s Orbital Atherectomy Systems 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. As of June 30, 2018, over 392,000 of CSI’s devices have been sold to leading institutions across the United States and Japan.
 
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.