MICHIGAN CRITICAL CARE CONSULTANTS, INC. — Department of Health and Human Services SBIR Phase I: NICHD

Description

ABSTRACT Extracorporeal membrane oxygenation ECMO use continues to increase as a supportive measure for cardio respiratory failure Pediatric patients with severe acute left ventricular LV systolic dysfunction are often supported with venoarterial VA ECMO as a short term bridge to recovery transplant or a ventricular assist device VAD Although this often provides the much needed temporary gas exchange and increase in cardiac output to all important end organs lack of egress of blood from the LV can lead to over distension and elevated LV end diastolic pressure LVEDP which reduces myocardial oxygen delivery and recovery The risk of progressive increase in left sided filling pressures needs to be monitored closely to avoid the deleterious effects of left heart distention Left ventricular distention in patients with profoundly reduced left ventricular contractility is a major risk factor for poor myocardial recovery and failure to wean from ECMO Mechanical decompression of the left heart during ECMO is sometimes required to address ventricular distention and is often a life saving intervention For patients who do not have open access to the heart for surgical decompression i e post operative cardiac patients left ventricular decompression is most commonly accomplished by percutaneous transseptal puncture followed by either septostomy or placement of a drain or device to keep the atrial communication patent Due to the lack of a FDA approved devices for this indication all options of decompression represent off label use of devices not specifically designed for this intervention The goal of this project is to design test and produce a line of pediatric and adult ventricular assist catheters VAC that can be used for short term left heart decompression in patients on VA ECMO for acute severe LV systolic dysfunction The MC VAC line will include lengths and diameters to cover the entire spectrum of sizes required for the pediatric population for both low flow left heart decompression and high flow total ventricular assist The largest size catheters will also support the adult patient so the line will be designed to truly match the entire patient spectrum Phase I of the study will include capturing detailed design inputs for the population by analyzing pediatric patient data from clinical cases at The University of Michigan User requirements will be translated into design inputs outputs by MC andapos s team of experienced cannula design engineers who have designed several commercially successful cannula and introducer systems Feasibility will be established by evaluating performance of the VAC against specific criteria unique to usage in the pediatric application Phase II funding if granted will be sufficient to complete verification validation testing transfer to manufacture and FDA and CE mark submissions We have assembled a synergistic team of experts clinicians marketers manufacturers and engineers who are uniquely qualified to carry out the proposed work NARRATIVE Extracorporeal Membrane Oxygenation ECMO has become a widely accepted means to provide short term circulatory support for pediatric and adult patients suffering from acute cardiac failure The biggest problem for cardiac ECMO is that complications can arise when pressure builds in the heart and unloading or decompression of the left side is frequently required The goal of this project is to develop a pediatric and adult line of cardiac catheters that can be used to decompress the left heart in patients on ECMO as well as a full circulatory assist catheter device if indicated Currently there is no such catheter solely approved for this use in pediatrics and options are limited for adults