To evaluate the performance of the Merit Medical WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY device). The WRAPSODY device is used to treat a blocked or narrowed vein you have in your dialysis access circuit that affects your blood flow during dialysis (treatment that removes waste and excess fluid from your blood).
The purpose of this research is to evaluate the efficacy of a new investigational Sirolimus coated balloon device in the treatment of insufficient blood flow of legs (peripheral arterial disease, PAD).
This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.
To evaluate the safety and effectiveness of direct carotid access for stenting using
the Neuroguard IEP® Direct System in subjects at elevated risk for adverse events
following carotid endarterectomy (CEA).