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Cardiac Ventricular Assist Catheter

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HD088243-01A1
Agency Tracking Number: R43HD088243
Amount: $209,536.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA15-269
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-19
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Dexter, MI 48130-1563
United States
DUNS: 806687406
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (734) 995-9089
Business Contact
Phone: (734) 995-9089
Research Institution

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

* Information listed above is at the time of submission. *

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