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Shim System for Removing ICD Artifacts from Patient Cardiac MR Images

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL166053-01
Agency Tracking Number: R41HL166053
Amount: $309,942.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-15
Award End Date (Contract End Date): 2023-08-31
Small Business Information
452 ASH ST
Brockton, MA 02301-5060
United States
DUNS: 928738756
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (774) 240-7100
Business Contact
Phone: (508) 269-9344
Research Institution
BALTIMORE, MD 21218-2680
United States

 Nonprofit College or University

Project Abstract1.4 million people in the US (2021) have implanted cardioverter-defibrillators (ICDs) of which ~50% will
require an MRI scan in their lifetime. All ICDs generate large artifacts in MRI such as signal-voids in cardiac MR
(cMR) images, which frequently occur in important pathological (infarcted) regions. Reliable diagnosis of
ventricular tachycardia, premature ventricular contraction and myocarditis using cMR is therefore prevented, as
well as MR-guided therapy of these potentially life-threatening diseases. The scanner’s own shim coils cannot
correct these large inhomogeneities, so powerful dedicated resistive shim coils are required.It is proposed that a Cardiac Shim System (CSS), consisting of a mechanical frame for accurate shim-coil
placement, a shim coil, a programmable power supply, electromagnetic filtering circuits, shim-coil placement
optimization software, and system-use protocols can be used to precisely reduce artifacts in a user-determined
region of the heart. The innovative CSS design does not interact with, and is not acted upon by, the rf coils and
the gradient coils of the scanner, maintaining the scanner’s specified performance. Furthermore, the magnetic
forces acting upon the CSS are balanced, permitting the shim coil to be moved freely within the MRI scanner
bore and maximizing patient safety.Aim 1 of this Phase I STTR project is to develop a commercial prototype (V2), based upon the initial proof-
of-concept system (V1), to be used on a Siemens 1.5T MRI scanner at JHU. This includes refinements in shim
coil design, software reconstruction, protocol development, and the development of a motorized positioning
system. In Aim 2, it is proposed, to test this novel system quantitatively using 5 infarcted swine and 6 human
volunteers to demonstrate CSS effectiveness in performing cMR safely using standard cardiac MRI protocols
such as LGE and cine. Future Phase 2 efforts will pursue clinical testing to prepare for submission to the FDA
for regulatory clearance.Project Narrative
1.4M patients (US) have implantable Cardiac Defibrillators (ICDs) that create large artifacts in cardiac MR
images, which frequently occur in important pathological regions of the heart preventing reliable diagnosis of
various heart diseases. We propose to build and test a Cardiac Shim System to reduce these artifacts
in a user determined region of the heart. Testing and validation will be performed in phantoms,
infarcted swine, and human volunteers to demonstrate the effectiveness of the device.

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

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