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3D Holographic Guidance, Navigation, and Control (3D GN&C) for Endovascular Aortic Repair (EVAR)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL139290-01A1
Agency Tracking Number: R41HL139290
Amount: $223,868.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-02-15
Award End Date (Contract End Date): 2019-08-14
Small Business Information
Cleveland, OH 44106-2119
United States
DUNS: 080088507
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (440) 567-6177
Business Contact
Phone: (440) 533-1950
Research Institution
CLEVELAND, OH 44195-0001
United States

 Domestic Nonprofit Research Organization

Project Summary
This project will develop newD visualization to improve stent graft deployment during minimally invasive
endovascular aortic repairEVARby overcoming limitations ofD x ray fluoroscopyfluoroD holographic
guidancenavigation and controlD GNandamp Cwill be provided to decrease fluoro radiation dose burden to
patients and OR staff during treatment of aortic aneurysmsparticularly when deploying stent grafts within
hostile aortic anatomywith challenges such as short and or angled landing zonesRadiation freeD GNandamp C
that is not limited by aD display will enable accurate stent graft positioning with less irradiationand thus
fewer postoperative complications or need for re interventionThis innovation will also expand the patient
population eligible for EVARparticularly those with highly unfavorable aortic anatomyas the demand and
utilization of the minimally invasive approach continues to riseD GNandamp C for EVAR will be developed and integrated with our computer assisted surgical platformthe IntraOperative Positioning SystemIOPSThe Guidance subsystem digitally augments the surgical field novel
with holographic representations of the virtual stent graft deployment device within a patient specific digital
aortic model for targeting the aneurysmandapos s landing zone using a modernself contained augmented mixed
reality headsetNavigation uses innovative methods to accurately track in real time theD position and
orientation of present and next generation stent graft delivery devices as well as sensor coil equipped wires
and catheters in a low levelsafe electromagneticEMfieldControl indicatorsbased on EM tracking data
and the guidance planalso augment the aorta and stent graft digital models to suggest maneuvers of the
delivery device as it approaches the aneurysm s proximal neck landing zoneThe feasibility criteria are to demonstrate thatD GNandamp C can be used to decrease fluoro radiation dose while
accurately deploying EVAR stent grafts within challenging aneurysm anatomy using state of the art delivery
devicesThe Specific Aims include evaluation of GNandamp C usability with a standard scalea bench study to verify
accurate stent graft deployment withinD printed complex aortic morphologyand a preclinical porcine study
to prove thatat this stage of R Randamp DD GNandamp C used as an adjunct to fluoro can decrease fluoro radiation
dose relative to fluoro alonewith comparable stent graft deployment accuracy and procedure timeMeeting all acceptance criteria of the Specific Aims will lead to a future clinical study in STTR Phaseto
demonstrate safetyeffectivenessand efficiency of stent graft deployment usingD GNandamp CImproved stentgraft placement and overcoming limitations of fluoro will pave the way to realizing the full clinical and economic
benefits of EVAR over highly invasive open surgical repairThe ultimate reach goes beyond aneurysmal
disease to include aortic dissectionadditional endovascular proceduresand other minimally invasive
applications to further benefit a broader population of patients and caregivers as well as global healthcare Project Narrative
This project provides newD visualization with mini GPS like guidancenavigationand control to precisely
thread a stent graft through arteries to an aortic aneurysmor other vascular lesionduring minimally invasive
surgeryD visualization displayed at the operative site will decrease the use ofD x ray fluoroscopy while
surgeons accurately anchor a stent graft inside an aortaresulting in fewer complications after surgery and
less x ray radiation exposure to patients and surgical staffAdvantages of this procedure over open surgery will
be fully realized as surgeons increasingly choose itleading to improvements in cost and quality of care for the
healthcare systemwhile improving quality of life for both patients and their caregivers

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

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