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Cardiac Ventricular Assist Catheter

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HD088243-02
Agency Tracking Number: R44HD088243
Amount: $1,490,255.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-08-01
Award End Date (Contract End Date): 2022-01-31
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

ABSTRACTExtracorporeal 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). ECMO provides temporary gas exchange and increased cardiac output to 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, as 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, placement
of a drain device to keep the atrial communication patent, and placement of a pVAD such as Impella 2.5 which
is only available for adults, is hemolytic, and is extremely expensive. Due to the lack of an FDA-approved
device for this indication, options for decompression represent off-label use, and none of these devices is
designed for pediatrics.The goal of this project is to design, test, and produce a line of pediatric and adult left heart decompression
catheters suitable to be used in patients on VA ECMO for acute, severe LV systolic dysfunction. The MC3
InterSeptâ„¢ catheter line will include lengths and diameters to cover the entire spectrum of sizes required for
the pediatric population from 2 kg to fully-grown patients, for both low flow left heart decompression and high
flow total ventricular assist. Phase I captured detailed design inputs for the population by analyzing pediatric
CT scan data from clinical cases at The University of Michigan. User requirements were translated into design
inputs/outputs by MC3andapos;s team of experienced cannula design engineers. Feasibility was established by
evaluating performance of the InterSept against specific criteria unique to use in the pediatric application. With
Phase II funding, the full range of InterSept will be optimized, verification/validation testing will be completed,
the design will be transferred to in-house MC3 manufacturing, and FDA and CE mark submissions will be filed
using the ECMO pathway in the US and the Class 3 CE Mark pathway in accordance with the new European
Medical Device Regulation. 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) is increasing and has become a widely accepted means to
provide support for pediatric and adult patients suffering from acute cardiac and/or pulmonary 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, with potential to be used as a full circulatory assist catheter 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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