Cardiovascular Systems’ Peripheral Orbital Atherectomy Device Debuts in Europe

Cardiovascular Systems Inc. (CSI), a medical device company developing and commercializing interventional treatment systems for patients with peripheral and coronary artery disease, revealed that the first patient in Europe has been treated with its Stealth 360 Peripheral Orbital Atherectomy System (OAS) 1.25mm Micro Crown with GlideAssist (1.25 Micro Crown).
 
The 1.25 Micro Crown is designed with flexibility for tortuous vessels and tight bends below the knee. The GlideAssist feature enables the crown to spin at a slow speed of 5K rpm, facilitating tracking and smoother movement to access diffuse, calcified lesions below the knee.
 
Dr. Michael Lichtenberg, chief physician, Clinic for Angiology, Hochsauerland Hospital, Arnsberg, Germany, successfully treated the first peripheral patient with the 1.25 Micro Crown.
 
“CSI’s new Stealth OAS 1.25 Micro Crown with GlideAssist is a welcome addition to my toolbox for treating challenging critical limb ischemia, or CLI, cases. In particular, the device’s dual mechanism of action of differential sanding and pulsatile forces will be instrumental in the treatment of the challenging calcified lesions I often see in lesions below the knee,” Dr. Lichtenberg said.
 
Scott Ward, chairman, president and CEO of CSI, said, “With our distribution partner, OrbusNeich, we are excited to introduce the 1.25 Micro Crown in Germany. One million German patients suffer from CLI, a severe condition that can result in severe pain, tissue damage and loss of limbs. The 1.25 Micro Crown provides physicians with a minimally invasive therapy to access and effectively treat this condition by modifying calcified lesions below the knee and restoring blood flow to the foot.”
 
Cardiovascular Systems Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. 

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.
 
The Stealth 360 PAD System and Diamondback 360 PAD System received U.S. Food and Drug Administration 510(k) clearance. The Stealth 360 PAD System is CE Marked.