Business Wire02.07.19
Cardiovascular Systems Inc. (CSI) has announced that the first patients in the United States were treated using the OrbusNeich Teleport Microcatheter (Teleport), which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Microcatheters are used to provide support and safe guidewire exchange during complex cardiovascular procedures. Teleport is a new generation microcatheter designed for deliverability and support, with a unique and robust tip designed to enable access in the most challenging lesions.
Annapoorna S. Kini M.D., director of the Cardiac Catheterization Laboratory at Mount Sinai Medical Center, New York, N.Y., and Emmanouil Brilakis, M.D., Ph.D., FACC, FAHA, FESC, FSCAI, interventional cardiologist at Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minn., treated the first patients in the United States with Teleport.
Said Dr. Kini, “I am excited and honored to be the first to use Teleport microcatheter in the United States. Teleport allowed me to deliver the microcatheter easily through tortuous coronary vasculature while maintaining catheter position for guidewire exchange treating a complex chronic total occlusion.”
Dr. Brilakis, added, “I had the opportunity to use the Teleport Microcatheter in Europe and was impressed by its balance of deliverability and support. Teleport’s robust tip design is unique, enabling access to tight lesions while providing the torqueability necessary to treat very challenging lesions. I’m excited to have this device available to treat my patients here in the United States.”
Scott Ward, CSI’s Chairman, president and CEO, said, “We are committed to building a comprehensive cardiovascular company and leveraging our commercial footprint and clinical value to become the partner of choice in the revascularization of patients with complex peripheral and coronary artery disease. The clearance of the Teleport Microcatheter complements our emphasis on providing advanced solutions for the most difficult coronary and peripheral lesions.”
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.
Cardiovascular Systems Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative 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 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.
Microcatheters are used to provide support and safe guidewire exchange during complex cardiovascular procedures. Teleport is a new generation microcatheter designed for deliverability and support, with a unique and robust tip designed to enable access in the most challenging lesions.
Annapoorna S. Kini M.D., director of the Cardiac Catheterization Laboratory at Mount Sinai Medical Center, New York, N.Y., and Emmanouil Brilakis, M.D., Ph.D., FACC, FAHA, FESC, FSCAI, interventional cardiologist at Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minn., treated the first patients in the United States with Teleport.
Said Dr. Kini, “I am excited and honored to be the first to use Teleport microcatheter in the United States. Teleport allowed me to deliver the microcatheter easily through tortuous coronary vasculature while maintaining catheter position for guidewire exchange treating a complex chronic total occlusion.”
Dr. Brilakis, added, “I had the opportunity to use the Teleport Microcatheter in Europe and was impressed by its balance of deliverability and support. Teleport’s robust tip design is unique, enabling access to tight lesions while providing the torqueability necessary to treat very challenging lesions. I’m excited to have this device available to treat my patients here in the United States.”
Scott Ward, CSI’s Chairman, president and CEO, said, “We are committed to building a comprehensive cardiovascular company and leveraging our commercial footprint and clinical value to become the partner of choice in the revascularization of patients with complex peripheral and coronary artery disease. The clearance of the Teleport Microcatheter complements our emphasis on providing advanced solutions for the most difficult coronary and peripheral lesions.”
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.
Cardiovascular Systems Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative 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 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.
