Core Insights - Nuwellis, Inc. has received FDA 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC), enhancing its fluid management technology platform [1][2][5] Company Strategy - The clearance aligns with Nuwellis' multi-year plan to develop a comprehensive fluid management platform that integrates therapy delivery, venous access, and implementation support for hospitals and clinics [2][3] - The company's growth strategy focuses on three key areas: critical care, cardiac surgery recovery, and outpatient heart failure programs [2] Product Details - The dELC is designed for reliable peripheral venous access for up to 72 hours, supporting the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy [4][7] - The product portfolio now includes two coil-reinforced, 6F catheters with insertable lengths of 11 cm and 15 cm, catering to various patient anatomies and clinical workflows [5][9] Clinical Relevance - The dELC aims to provide dependable peripheral access across inpatient and outpatient settings, enhancing workflow efficiency and therapy delivery confidence [3][9] - The Aquadex SmartFlow system is indicated for temporary or extended use in patients with fluid overload unresponsive to medical management, emphasizing its clinical applicability [7]