Topline: In a multicenter registry of 91 critically ill pediatric patients treated with the Aquadex ultrafiltration system, 92% survived their treatment course, 66% survived to hospital discharge, and 86% of circuits completed the intended course without interruption. Circuit longevity was longer with heparin than with bivalirudin anticoagulation.
Nuwellis reported real-world results from the ULTRA-Peds registry across eight U.S. centers in children with acute kidney injury, fluid overload, or congenital kidney failure. The cohort included substantial complexity, with congenital heart disease, end-stage renal disease, and malignancy among the leading diagnoses. While Aquadex is FDA-cleared for adults and pediatric patients weighing at least 20 kg, the registry comprised two arms: a retrospective review that captured some sub‑20 kg uses already completed in practice, and a prospective, on‑label arm. Beyond procedural outcomes, the registry highlights operational variables—most notably anticoagulation choice—that affect circuit performance and resource utilization in pediatric ICUs.
Strategically, the dataset does double duty: it validates the feasibility and tolerance of Aquadex in a fragile population while seeding the company’s pivot toward a purpose-built pediatric CRRT platform, Vivian, designed for patients 2.5–20 kg. With a recently awarded $3 million NIH development grant and new patents, Nuwellis is signaling a staged approach—use observational evidence to map care patterns and pain points, then channel those insights into a device engineered for neonatal and small-child physiology. The bet is that pediatrics will reward fit-for-purpose design over continued reliance on scaled-down adult systems, and that integrated cardio-renal management can be an organizing theme for portfolio expansion.
For sites, the immediate takeaway is pragmatic. The registry suggests anticoagulation strategy materially influences circuit durability, a lever that directly impacts nursing workload, blood exposure, and cost of disposables. PICUs using Aquadex on-label can benchmark circuit survival and discharge rates against their own experience, while centers that have historically cared for sub‑20 kg patients using adapted platforms will see the outlines of a dedicated alternative emerging. IRBs and risk committees may revisit oversight for off-label extracorporeal support in infants as Vivian moves into clinical evaluation. For sponsors and CROs, the registry offers realistic endpoint candidates—treatment-course survival, circuit survival, fluid balance metrics—and a signal on subgroup heterogeneity that will inform stratification, anticoagulation protocols, and power assumptions. Vendors should note the training and workflow implications; if Vivian reduces extracorporeal volume and embeds real-time monitoring, it could shift staffing models and reduce the learning curve, factors that drive hospital procurement decisions as much as raw efficacy.
What’s next is execution risk on multiple fronts. Nuwellis will need to define Vivian’s regulatory path—de novo, HDE, or another route—along with a clinical program capable of demonstrating not only procedural safety but meaningful impact on hemodynamics, fluid balance, and renal recovery in neonates and small children. Timing of an IDE submission, multicenter site readiness, and anticoagulation standardization will be early signals. Watch for whether the company seeks to expand Aquadex labeling based on the retrospective data, how it positions Vivian relative to incumbent platforms already adapted for pediatrics, and whether it can scale manufacturing, field support, and training to meet PICU requirements. The operational question for the field is whether purpose-built pediatric CRRT can convert registry-era feasibility into reproducible outcomes and a sustainable service model in environments constrained by staffing and capital budgets.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
