Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures

Kurzzusammenfassung

This is an early feasibility, pre-market, prospective, interventional, single-arm, non-randomized / open-label study intended to support a future pivotal IDE study for eventual FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.