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Clinical Studies

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LEADER First In Man (FIM) feasibility study designed to evaluate safety and debris removal performance of the PROTEUS device in diseased Superficial Femoral Arteries (SFA)

EuroPCR 2008, Barcelona
MC-LEADER Multi- center study designed to evaluate  safety and efficacy of the PROTEUS device during lower extremity Percutaneous Transluminal Angioplasty  (PTA) [Study was conducted as part of 510(k) submission].

Reference: Zeller T, Schmidt A, Rastan A, Noory E, Brechtel K, Sixt S,Scheinert D, Tepe G. New approach to protected percutaneous transluminal angioplasty in the lower limbs. J Endovasc Ther. 2013 May;20(3):409-19
PROTEUS™ 5x300mm Catheter Study Multi-center study designed to confirm safety of PROTEUS 5x300mm device in long femoropopliteal lesions.

Reference: Zeller T, Schmidt A, Rastan A, Noory E, Sixt S, Scheinert D. Initial experience with the 5x300-mm proteus embolic capture angioplasty balloon in the treatment of peripheral vascular disease. J Endovasc Ther. 2012 Dec;19(6):826-33
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