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

SUBMITTER: Maul TM 

PROVIDER: S-EPMC3594505 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature