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

Description

Project Summary This project will develop newD holographic guidance and navigationD Visualizationto overcome limitations of conventional imaging methods used to treat aortic stenosisASwith transcatheter aortic valve replacementTAVRD Visualization will improve safety and effectiveness of TAVR over use of x ray fluoroscopyfluoroand transesophageal transthoracic echocardiography displayed on conventional flatD monitorsThis new method augments dynamicDi eDholographic cardiovascularCVmodelsincluding aortic rootcoronariesleft ventriclewith models of TAVR delivery devices to the operative siteThis will result in increased accuracy of delivery device positioning leading to fewer complicationse gcoronary occlusionheart blockvalve regurgitationas well as lower fluoro radiation dose to patients and staffThis innovation will improve outcomes of TAVRwhose adoption is rapidly expanding as a less invasivebetter performingand more economical alternative to surgical aortic valve repairIn the nextyearsTAVR is expected to exceedof the aortic valve replacement market and will continue to lead the new era of transcatheter cardiac careD Visualization for TAVR is the first image guidance method to augment time varyingi emovingD CV holograms to the operative site in real time registration with a balloon catheter and guidewireThe benefits of combinedD guidance and navigation are achieved by integrating our electromagneticEMnavigation system with guidance provided by Microsoft s HoloLensa modernself containeduntetheredcost effectiveaugmentedmixed reality headsetThe HoloLens augments ECG synchronized CV holograms derived from cardiac CT in registration with EM tracked TAVR delivery devices in patient coordinatesHolographic feedback will improve valve implantation depth and co axial alignment positioning relative to the aortic root annulusTo demonstrate thatD Visualization improves TAVRour feasibility criteria are to increase tracked delivery device positioning accuracy while decreasing fluoro radiation doseIn the bench studyAimD printed CV models will be integrated with a pulsatile flow circuit to meet the implantation depth and co axial alignment positioning accuracy criteriaAimwill prove thatD Visualization meets standard system usability criteriaIn the live porcine studyAimwe will show thatD Visualizationused as an adjunct to fluorocan significantly increase deployment accuracy while decreasing radiation dose relative to fluoro aloneMeeting the acceptance criteria will lead to further clinical validation in SBIR Phase II to demonstrate safetyeffectivenessand efficiency of valve deployment usingD VisualizationImproved valve positioning and overcoming limitations of fluoro only will pave the way to the full healthcare economic benefits of TAVR over surgical valve repairThe ultimate reach goes beyond aortic valve disease to include transcatheter treatment of other structural heart diseasese gmitral valve stenosis or insufficiencyto further benefit a broader population of patients and caregivers as well as global healthcare economics Project Narrative This project provides new four dimensionalD or dynamicDholographic visualization of a beating heart and mini GPS like navigation of small catheters and guidewires to precisely replace a diseased aortic valveUse ofD visualization superimposed to the operative site instead of flat x ray images will improve valve positioning leading to fewer complications as well as decrease exposure of patients and surgical staff to x ray radiationAdvantages of this procedure over surgical valve implantation will be fully realized as adoption of minimally invasive procedures continues to transform heart careleading to improvements in quality and cost benefits to healthcare worldwide