Cardiovascular disease (CVD) is the leading cause of mortality in the United States (US), resulting in 850,000 annual deaths, of which nearly 400,000 are associated with coronary heart disease (CHD) and myocardial infarction (MI). By 2030, global annual deaths will exceed 20 million. More than 90 million US adults currently live with CVD, which is associated with an annual economic burden of more than $330 billion. Together, MI and CHD are the most expensive conditions treated in US hospitals, totaling more than $20 billion each year, with costs expected to double by 2030. Percutaneous coronary intervention (PCI) is an effective strategy to restore blood flow for obstructive CHD. However, while nearly 950,000 PCI procedures are performed each year in the US, navigating tortuous vessels is challenging and enabling stent expansion within severely calcified occlusions often fails, which are observed in ~35% and ~20% of procedures, respectively.Rotational atherectomy (RA) and orbital atherectomy (OA) are increasingly used to debulk otherwise untreatable lesions to enable PCI, with recent studies confirming RA and OA improve stent deliverability vs. standard PCI without negatively affecting outcomes. To debulk severely calcified lesion, RA/OA devices employ long (>300cm) stiff driveshafts which spin burrs/crowns at speeds up to 180,000 RPM. For both RA and OA, the inflexible driveshaft often hinders access within tortuous vasculature. The high speeds employed are necessary to stabilize the burr/crown about a guidewire, without which, the tip would dangerously whip. However, the need for extreme rotational speeds greatly increases the complexity of RA/OA systems and presents risks, which include 1) thermal injury due to driveshaft friction, 2) arterial abrasion and perforation, 3) guidewire shattering, 4) burr/crown entrapment, and 5) embolic debris within the distal vasculature. To reduce the risk of traumatic injury, RA and OA devices cannot be used for more than five minutes.UNandUP has developed an interventional cardiology platform consisting of a magnetic access guidewire and an over-the-wire rotational atherectomy catheter which are controlled using magnetic fields 100X weaker than an MRI. The magnetic guidewire overcomes vessel tortuosity to improve lesion access, a desirable feature for PCI in general. For the magnetic atherectomy catheter, applying magnetic forces directly to the burr eliminates the need for 100X higher driveshaft speeds to stabilize tip rotation. Resultingly, safer and more efficacious debulking is achieved. Further, driveshaft removal enables concurrent aspiration of embolic debris near the burr, a feature not possible with current atherectomy devices. The team reflects leading cardiology, RA/OA, magnetics, and robotics experts. The company maintains partnerships with leading national laboratories and recently completed an FDA presubmission meeting and I-Corps participation. The proposals aims include building a prototype magnet system, building magnetic guidewire and atherectomy devices, and evaluating the systems performance in tortuous cardiac phantoms and published lesion models. Public Health Relevance Statement Cardiovascular disease is the leading cause of death, with coronary heart disease and myocardial infarction resulting in nearly 400,000 deaths in the US each year. For over 25 years, rotational and orbital atherectomy have been successful in enabling stent deliverability in severely calcified coronary lesions. However, the unique capabilities of these valuable tools have not evolved due to fundamental mechanical limitations, which include obtaining access within tortuous vasculature, adverse heating, arterial perforation, and generation of embolic debris. For this proposal, UNandUP (short for Unmet Needs and Underserved Populations) will demonstrate proof of concept of a novel magnetic guidewire and rotational atherectomy platform that greatly improves vascular access while providing, for the first time, concurrent aspiration of embolic debris at the burr.
Project Terms: Adult ; 21+ years old ; Adult Human ; adulthood ; Angiography ; Angiogram ; angiographic imaging ; Animals ; Blood ; Blood Reticuloendothelial System ; Blood Vessels ; vascular ; Cadaver ; Cardiology ; Cardiovascular Diseases ; cardiovascular disorder ; Cause of Death ; Coronary heart disease ; Coronary Disease ; atherosclerotic heart disease ; coronary disorder ; Dental crowns ; Crowns ; Dangerousness ; Cessation of life ; Death ; Eligibility Determination ; Eligibility ; Protocol Screening ; Feasibility Studies ; Glycerol ; 1,2,3-Propanetriol ; 1,2,3-Trihydroxypropane ; Glycerin ; Goals ; Gold ; Heart ; Heating ; State Hospitals ; Human ; Modern Man ; In Vitro ; Lavage ; Nonvaginal irrigation ; Nonvaginal lavage ; irrigation therapy ; lavage therapy ; other than vaginal Douching ; other than vaginal Irrigation ; Irrigation ; Laboratories ; MR Imaging ; MR Tomography ; MRI ; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance ; NMR Imaging ; NMR Tomography ; Nuclear Magnetic Resonance Imaging ; Zeugmatography ; Magnetic Resonance Imaging ; Manuals ; Maps ; Methodology ; mortality ; Cardiac infarction ; Myocardial Infarct ; cardiac infarct ; coronary attack ; coronary infarct ; coronary infarction ; heart attack ; heart infarct ; heart infarction ; Myocardial Infarction ; NIH ; National Institutes of Health ; United States National Institutes of Health ; Patents ; Legal patent ; Powders ; Powder dose form ; Publishing ; Research ; Risk ; Robotics ; Rotation ; Stents ; Testing ; Time ; Echography ; Echotomography ; Medical Ultrasound ; Ultrasonic Imaging ; Ultrasonogram ; Ultrasound Diagnosis ; Ultrasound Medical Imaging ; Ultrasound Test ; diagnostic ultrasound ; sonogram ; sonography ; sound measurement ; ultrasound ; ultrasound imaging ; ultrasound scanning ; Ultrasonography ; United States ; Viscosity ; Diamond ; Generations ; Measures ; Catheters ; Device Designs ; Dataset ; Data Set ; Percutaneous Atherectomy ; Percutaneous Transluminal Atherectomy ; Transluminal Atherectomy ; Atherectomy ; Rotational Atherectomies ; Friction ; Calcified ; calcification ; base ; improved ; Procedures ; Distal ; Surface ; Acute ; Chronic ; Encapsulated ; Phase ; Lesion ; Blood flow ; Measurement ; thermal injury ; heat injury ; tool ; Torque ; mechanical ; Mechanics ; Debulking ; cytoreductive surgery ; surgical cytoreduction ; tumor cytoreduction ; Tumor Debulking ; System ; Perforation ; meetings ; Services ; magnetic ; Magnetism ; magnetic field ; biocompatibility ; biomaterial compatibility ; Performance ; Animal Models and Related Studies ; model of animal ; model organism ; Animal Model ; Speed ; novel ; Devices ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; Position ; Positioning Attribute ; Modeling ; portability ; Intervention Strategies ; interventional strategy ; Intervention ; Institution ; preventing ; prevent ; Length ; Economic Burden ; in vivo ; To specify ; Cardiac ; percutaneous coronary intervention ; coronary calcification ; coronary artery calcification ; safety study ; pathway ; Pathway interactions ; preclinical ; pre-clinical ; cost ; under served group ; under served people ; under served population ; underserved group ; underserved people ; Underserved Population ; design ; designing ; Outcome ; Coupled ; prototype ; effective therapy ; effective treatment ; safety testing ; comparative efficacy ; compare efficacy ; arm ; 3D Print ; 3-D print ; 3-D printer ; 3D printer ; 3D printing ; three dimensional printing ; Innovation Corps ; I-Corps ; Traumatic injury ; negative affect ; negative affectivity ; efficacy study ; coronary lesion ; safety assessment ;
