Pre-clinical Implants of the Levitronix PediVAS® Pediatric Ventricular Assist Device: Strategy for Regulatory Approval

Abstract

The PediVAS blood pump is a magnetically levitated centrifugal pump designed for pediatric bridge-to-decision or bridge-to-recovery in pediatric patients from 3–20kg in weight. In preparation for submission of an investigational device exemption (IDE) application, we completed a final six-animal series of pre-clinical studies. The studies were conducted under controlled conditions as prescribed by the recently released FDA guidance document for animal studies for cardiovascular devices. Three 30-day chronic left ventricular support studies were completed in a juvenile lamb model to demonstrate the safety and hemocompatibility of the PediVAS pump. Three additional 8-hour acute biventricular support studies were performed to demonstrate the feasibility of this approach from a hemodynamic and systems standpoint. It is estimated that 50% of pediatric patients who require left ventricular support also require right ventricular support. All studies were successfully completed without complications, device malfunctions, or adverse events. End-organ function was normal for the chronic studies. We noted small surface lesions on one kidney from each chronic study as well as the presence of ring thrombus on connectors, as expected for these types of studies in animal models. The strategy and challenges imposed by performing a controlled cardiovascular device study in a juvenile lamb model are discussed. We believe that these successful implants demonstrate safety and performance for the PediVAS device for support of an IDE application to initiate human clinical trials and provide a roadmap for other researchers.

Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump

“…However, it is misleading to extrapolate that a lower pump flow leads to less blood damage [10,15]. To date, there are only a few pumps that have been designed for these requirements or tested in the low-flow range [16][17][18][19]. This highlights the urgent need to focus on technical implications associated with the use of current centrifugal blood pumps in different low-flow ranges.…”

In Vitro and In Vivo Performance Evaluation of the Second Developmental Version of the PediaFlow Pediatric Ventricular Assist Device

“…Such observations have been reported for other investigational devices in ovine models. 8,11,18 The histopathologic findings suggested that these infarctions were well-healed, and occurred early in the post-operative period. A potential cause may have been heightened inflammatory response and platelet activation, such as evidenced by elevated and variable neutrophil counts in PF2.2 from a confirmed fecal culture for whipworm.…”