The first patients in Germany have been treated with the Stealth 360 Peripheral Orbital Atherectomy System (OAS; Cardiovascular Systems Inc). The German cases represent the first commercial use of Peripheral OAS in Europe.
Tobias Achenbach, head of the Radiology Department at the St Vincenz Hospital, Cologne, Germany, where the first patients in Germany were treated, says, “CSI’s minimally invasive orbital atherectomy technology allows physicians to gently modify calcified plaque and enables peripheral revascularisation for patients with severely calcified arteries. The introduction of orbital atherectomy in Germany greatly improves the treatment options for my patients suffering from peripheral arterial disease.”
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 says, “Of those suffering from peripheral arterial disease, many progress to critical limb ischaemia, the most severe and potentially deadly form of peripheral arterial disease. If left untreated, critical limb ischaemia 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.”
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 USA and Japan.