Business Wire12.21.18
Cardiovascular Systems Inc. (CSI), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced that the first patient in Hong Kong has been treated with its Diamondback 360 Coronary Orbital Atherectomy System (OAS). This procedure marks the first international coronary procedure taking place as a result of the company’s distribution agreement with OrbusNeich.
Dr. Michael Kang-Yin Lee, MBBS, FACC, FRCP, director of Cardiac Catheterization Laboratory at the Division of Cardiology, Department of Medicine, Queen Elizabeth Hospital, Hong Kong, said, “Orbital Atherectomy is simple to use. It is a very controllable and predictable atherectomy device and is especially useful for diffuse and severely calcified coronary arteries, ensuring the angioplasty procedures can be completed with ease and good results. OAS also helps to fill the gap of the conventional devices when treating calcified coronary arteries.”
Scott Ward, chairman, president and CEO of CSI, said, “We are thrilled to begin introducing our proven coronary atherectomy technology to physicians worldwide. As our international distribution partner, OrbusNeich, identifies new markets, we are prepared to provide best-in-class training to physicians committed to improving patient outcomes within this underserved patient population.”
In July, CSI signed an exclusive international distribution agreement with OrbusNeich to sell its coronary and peripheral OAS outside of the United States and Japan.
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.
Teddy Chien, chairman emeritus and founder of OrbusNeich, added, “I was very pleased to have witnessed the first ever Coronary Orbital Atherectomy procedure performed in Hong Kong. CSI’s device supports our key business focus of providing solutions for all complex vascular interventions. We look forward to continuing global distribution of this clinically proven technology to our customers.”
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes 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.
Dr. Michael Kang-Yin Lee, MBBS, FACC, FRCP, director of Cardiac Catheterization Laboratory at the Division of Cardiology, Department of Medicine, Queen Elizabeth Hospital, Hong Kong, said, “Orbital Atherectomy is simple to use. It is a very controllable and predictable atherectomy device and is especially useful for diffuse and severely calcified coronary arteries, ensuring the angioplasty procedures can be completed with ease and good results. OAS also helps to fill the gap of the conventional devices when treating calcified coronary arteries.”
Scott Ward, chairman, president and CEO of CSI, said, “We are thrilled to begin introducing our proven coronary atherectomy technology to physicians worldwide. As our international distribution partner, OrbusNeich, identifies new markets, we are prepared to provide best-in-class training to physicians committed to improving patient outcomes within this underserved patient population.”
In July, CSI signed an exclusive international distribution agreement with OrbusNeich to sell its coronary and peripheral OAS outside of the United States and Japan.
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.
Teddy Chien, chairman emeritus and founder of OrbusNeich, added, “I was very pleased to have witnessed the first ever Coronary Orbital Atherectomy procedure performed in Hong Kong. CSI’s device supports our key business focus of providing solutions for all complex vascular interventions. We look forward to continuing global distribution of this clinically proven technology to our customers.”
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes 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.