First European Patients Treated With Cardiovascular Systems’ Peripheral Orbital Atherectomy System

Cardiovascular Systems Inc. (CSI), a medical device company developing and commercializing interventional treatment systems for patients with peripheral and coronary artery disease, announced that the first patients in Germany have been treated with its Stealth 360 Peripheral Orbital Atherectomy System (OAS). The German cases represent the first commercial use of Peripheral OAS in Europe.
 
Dr. Tobias Achenbach, head of the Radiology Department at the St. Vincenz Hospital, Köln, where the first patients in Germany were treated by his colleagues Dr. Reza Asady and Dr. Ingo Benz, said, “CSI’s minimally invasive orbital atherectomy technology allows physicians to gently modify calcified plaque and enables peripheral revascularization for patients with severely calcified arteries. The introduction of orbital atherectomy in Germany greatly improves the treatment options for my patients suffering from peripheral artery disease, or PAD.”
 
Prof. Dierk Scheinert, head of the Department of Medicine, Angiology and Cardiology, Park-Krankenhaus Leipzig, and head Department of Angiology, University Hospital Leipzig Heart Center, Leipzig, Germany said, “Of those suffering from PAD, many progress to critical limb ischemia, or CLI, the most severe and potentially deadly form of PAD. If left untreated, CLI can lead to amputation. The unique ability of orbital atherectomy to safely treat calcified peripheral lesions, both above and below the knee, will allow physicians in Germany to help a very challenging patient population.”
 
Scott Ward, Chairman, president and CEO of CSI, said, “By leveraging our international distribution partner, OrbusNeich, we are demonstrating our ability to rapidly introduce our OAS technology to physicians worldwide. We look forward to training many more physicians that share our passion for improving the outcomes of patients suffering from peripheral and coronary artery disease.”
 
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.
 
Cardiovascular Systems Inc., based in St. Paul, Minn., is developing and commercializing 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.