CENTERLINE BIOMEDICAL INC — Department of Health and Human Services STTR Phase I: NHLBI

Description

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