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Principal Investigator: Jared Hutar
Organization: PIRAEUS MEDICAL, INC.
Fiscal Year: 2024
Award: $982,021
Funding agency: National Institute of Neurological Disorders and Stroke
PROJECT SUMMARY/ABSTRACT
This proposal will improve the care of patients suffering from Acute Ischemic stroke (AIS). Catheter-based
thrombectomy has been established as the standard treatment for AIS. Still, substantial limitations remain: <50%
of patients achieve first-pass clot clearance, the best predictor of good neurological outcome, largely due to
shortcomings in the approach (transfemoral access [TFA]) and the current catheters used to aspirate clots.
Given the advanced age of many or most thrombectomy candidates, highly tortuous vessels are frequently
encountered when traversing from the femoral to carotid territories. It has been shown that substantial
tortuosity leads to worse outcomes in TFA procedures. Thus, many leading interventionalists have proposed
transradial access (TRA) in place of transfemoral access. TRA is already the preferred access site for the vast
majority of interventional cardiology procedures, given low rates of bleeding complications and ready access to
the coronary circulation. The radial site also provides ready access to the cerebral vasculature, bypassing
tortuosity along the aortic arch, descending aorta, and ilio-femoral system. However, neurointerventionalists
who use TRA are stuck employing femoral guide sheaths (such as the Ballast or Neuron Max), which are not
designed for the radial-to-intracranial navigation and which have safety concerns due to the vasospasm or
radial artery occlusion that can result from their imperfect adaptation to TRA.
A parallel advancement in neurointervention is that of SuperBore Distal Access Catheters (DACs) used to
efficiently pull out clots from arteries of patients suffering from AIS. These SuperBore DACs provide large
lumens (increasing suction by >30% over conventional DACs), but struggle with navigation challenges in
tortuous anatomies, with nearly half of procedures resulting in failure to navigate to the clot face. While they
provide a major advance in DAC sizing, SuperBores have not been considered for TRA approaches due to
their thick walls and stiff tips, precluding the ability to achieve optimized navigation or suction power from the
radial approach. Our team discovered this pressing need after achieving acquisition by Medtronic of our
previous SBIR-funded program via intensive interviews of 50+ physicians.
In our successful Phase I project, we developed and tested our novel SuperBore thrombectomy system
appropriate for TRA. Specifically, our “Wrist-to-Brain” thrombectomy system provides the distinct advantages
of: (1) combining guide catheter and SuperBore DAC in a single catheter, (2) hyperthin walls enabled by our
novel, proprietary liner, and (3) a highly trackable and kink resistant shaft that still fits within the radial artery in
most patients. In this Phase II SBIR program, we propose a full, formal validation program guided by FDA
testing criteria (Aim 1), followed by extensive benchtop, GLP animal, and cadaveric testing (Aim 2). This grant
will enable us to complete all testing needed to submit for FDA clearance and begin marketing our novel and
impactful Wrist-to-Brain thrombectomy system in order to improve the care of patients suffering from LVO AIS.
Terms: <Acute><Address><Adoption><Anatomic Sites><Anatomic structures><Anatomy><Animal Testing><Animals><Apoplexy><Area><Arterial Obstruction><Arterial Occlusion><Arteries><Artery Obstruction><Automobile Driving><Bleeding><Blood Clotting><Blood Vessels><Blood coagulation><Brain><Brain Nervous System><Brain Vascular Accident><Bypass><Cadaver><Cardiology><Catheters><Cause of Death><Cerebral Stroke><Cerebrovascular Apoplexy><Cerebrovascular Stroke><Cerebrovascular system><Characteristics><Circulation><Clinical><Clotting><Coagulation><Coagulation Process><Coronary><Coronary Circulation><Data><Descending aorta><Device Designs><Devices><Diameter><Dilator><Distal><Effectiveness><Elderly><Encephalon><Endothelium><Evolution><Extravasation><Face><Failure><Family suidae><Femur><Funding><Future><Goals><Grant><Groin><Hematoma><Hemorrhage><In Vitro><Inguinal region><Injections><International><Intervention><Intervention Strategies><Interview><Ischemic Stroke><Leadership><Leakage><Leanness><Length><Location><Marketing><Mechanical Aspiration><Mechanics><Medical><Modernization><Nerve Cells><Nerve Unit><Neural Cell><Neurocyte><Neurologic outcome><Neurological outcome><Neurons><Outcome><Patient Care><Patient Care Delivery><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Performance><Perfusion><Phase><Physicians><Pigs><Preclinical Testing><Procedures><Radial><Radius><Randomization trial><Resistance><Risk><Role><Route><Rupture><SBIR><Safety><Sales><Site><Small Business Innovation Research><Small Business Innovation Research Grant><Speed><Spillage><Stents><Stroke><Suction><Suction Drainage><Suidae><Swine><System><Testing><Thick><Thickness><Thinness><Thrombectomy><Torque><Vacuum><Validation><Vasospasm><Woman><Work><Wrist><advanced age><aortic arch><arterial tortuosity><artery occlusion><artery tortuosity><aspirate><blood loss><blood vessels in the brain><brain attack><brain blood vessels><brain vasculature><cadaveric><cadavers><care for patients><care of patients><caring for patients><cerebral blood vessel><cerebral vascular accident><cerebral vasculature><cerebrovascular accident><cerebrovascular vessels><cerebrovasculature><commercialization><design validation><design verification><disability><driving><elderly patient><experience><faces><facial><femoral artery><geriatric><improved><improved outcome><in vitro testing><in vivo><innovate><innovation><innovative><interventional strategy><mechanic><mechanical><men><neuronal><novel><older patient><patient oriented outcomes><porcine><pre-clinical testing><programs><radial artery><randomized trial><resistant><revascularization><senior citizen><social role><standard care><standard treatment><stroke patient><stroked><strokes><success><suid><usability><validations><vascular><vascular bed>