Development of a novel Balloon Occlusion Sheath for Stroke (BOSS)

PROJECT SUMMARY ABSTRACTThis research program s broadlong term objective is to improve health outcomes for patients suffering fromacute ischemic strokeAISresulting from large vessel occlusionsWe will achieve this purpose by developingimproved access tools for stroke intervention procedureswhich specifically target tool innovations that providesupport for embolectomy devices and arrest flow during the procedureBased on multiple landmarkrandomized trials inurgent embolectomy has displaced IV tPA as a standard of careLarge clinicalstudies have documented that the use of proximal occlusion balloonswhich stop antegrade flow whileretrieving the culprit embolus allowing aspiration of clot remnantshave numerous beneficial effects thatinclude quicker proceduresimproved rates of recanalizationand improved clinical outcomes as compared toprocedures done without such flow arrestIn current practicesuch balloons are used in onlyofprocedures due to substantial shortcomingsFor examplethey require very large access sheathsyet theirusable lumens are relatively smallFurthermorethey provide poor support for distal access devicesWe willdesign and develop improved balloon occlusion devices that overcome all shortcomings noted with currenttoolsthereby providing the community with highly stable balloon devices with lumens large enough to accepteven the largest distal access toolswhile using smaller arteriotomies to diminish access site bleeding riskIfsuccessfulour novel Balloon Occlusion Sheath for StrokeBOSSdevelopment program will lead to markedlyenhanced market penetration for the use of balloon occlusion maneuvers with resultant improvement in clinicaloutcomes Marblehead MedicalLLC proposes to create a new device to help treat stroke victimsRecentlyin addition to
using long flexible tubescathetersto reach into and unblock blood vesselsdoctors have used a balloon to
stop forward flow of the bloodwhich has been shown to improve outcomesHerewe combine a balloon with
a sheath to rapidly and safely guide any sized catheter so that doctors can employ both the balloon and the
catheter with one device