SBIR-STTR Award

Arrhythmias are due to irregular contractions and disorganized electrical signals within the heart and are a leading cause of death in the United States (US). Ventricular tachycardia and ventricular fibrillation are the most-serious arrhythmias and are associated with 300k annual US deaths. In comparison, atrial fibrillation (AF) impacts 6M Americans, making it the most common arrhythmia. With nearly 750k annual US hospitalizations and 130k annual US deaths, AF is associated with the highest medical costs, which are projected to exceed $50B by 2035. First-line AF therapies rely on pharmaceuticals to prevent blood clots and to restore proper rhythm. When these approaches fail, catheter ablation is an option. For this procedure, electrical currents (or coolants) are directed to the catheter’s tip to ablate those tissues disrupting normal electrical signals. Catheter ablation is an effective and increasingly-used therapy, with more than 500M procedures performed between 2000 and 2013. However, standard methods are complex and expose electrophysiologists to x-rays. Because manually-deflectable catheters rely on complex tension-wire designs that are operated from a meter away, errors accumulate in the transmission of forces and torques. As a result, precise catheter navigation and heart- wall contact are challenging, which can result in injury and AF recurrence (observed in ~50% of those treated). Robotic platforms attempt to address manual ablation catheter deficiencies. Standard robotic systems manipulate traditional manual catheters and place the electrophysiologist outside the x-ray field. However, the technology’s learning curve is high, catheter tip control is unimproved, and systems are expensive. Magnet- based robotic systems improve upon standard robotic systems by using magnetic fields to apply forces and torques directly to magnet-tipped catheters, which simplifies the catheters. The result is a technology that provides improved navigation and better heart-wall contact. However, magnet-based systems are impractically large, very expensive, hard to install, and difficult to use, in addition to requiring a new c-arm and magnetic shielding for the room. For these reasons, broad adoption of all AF robotic solutions has been slow. As opposed to expending energy in fighting the catheter’s restoring force, the proposed technology redesigns the catheter so that better catheter navigation and heart-wall contact are accomplished using a system whose magnetic field and mass are 6X and 40X smaller, respectively, than previously possible. The result is an affordable technology that 1) provides better catheter-tip control and heart-wall contact, 2) offers an open catheter lumen for electrical leads and irrigation, and 3) does not require custom c-arms and room construction. The team reflects commercially-successful magnetics, robotics, and electrophysiology experts. The Phase I effort focuses on proof of concept of the platform. The aims include 1) building the prototype magnet system, 2) building catheters and advancer, and 3) evaluating the system’s performance in beating heart phantoms. An FDA pre-submission meeting will be conducted in advance of the Phase II proposal.

Public Health Relevance Statement:
Arrhythmias represent a major cause of mortality, where ventricular fibrillation and ventricular tachycardia are associated with 300,000 annual deaths in the United States (US) and atrial fibrillation (AF), which affects nearly six million Americans, is associated with 130,000 annual deaths. As stated in the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement, catheter ablation is an effective treatment option; however, control of the catheter requires considerable skill, can be imprecise, and can result in variable heart-wall contact which, together, increase the likelihood of injury and arrhythmia recurrence. For this Phase I SBIR application, UN&UP (short for “Unmet Needs and Underserved Populations”) will demonstrate proof of concept of its patent-pending magnet-based electrophysiology robotic platform that provides superior ablative tip control against the heart wall and overcomes historical limitations related to usability, responsiveness, cost- effectiveness, and integrability.

NIH Spending Category:
Bioengineering; Cardiovascular; Heart Disease; Neurosciences

Project Terms:
Ablation; absorption; Acute; Address; Adoption; Affect; American; Angiography; Animal Model; arm; Arrhythmia; Articulation; Atrial Fibrillation; base; Biocompatible Materials; Biological; Blood; Blood coagulation; c new; Cardiac ablation; Catheters; Cause of Death; Cessation of life; Characteristics; Clinical; Complex; Consensus; Consult; cost; cost effective; cost effectiveness; Crystallization; Custom; Data Set; design; Devices; Docking; effective therapy; Electromagnetics; Electronics; Electrophysiology (science); Evaluation; Failure; Fatigue; fighting; Frequencies; Goals; Grain; Heart; heart rhythm; Hospitalization; improved; Injury; Irrigation; Learning; Legal patent; magnetic field; Magnetism; Manuals; Measures; Medical Care Costs; meetings; meter; Methodology; Methods; Microscopy; Modeling; mortality; novel; off-patent; Optics; Outcome; Performance; performance tests; Pharmacologic Substance; Phase; Positioning Attribute; pre-clinical; prevent; Procedures; prototype; Recurrence; robotic system; Robotics; Roentgen Rays; safety assessment; sensor; Signal Transduction; skills; Small Business Innovation Research Grant; source localization; Statistical Methods; Structure; success; Surface; System; Systems Integration; Technology; Tensile Strength; Time; Tissues; Torque; Torsion; Translating; transmission process; Underserved Population; United States; usability; Ventricular Fibrillation; Ventricular Tachycardia; Work

Arrhythmias result from disorganized electrical signals within the heart leading to irregular contractions and area leading cause of death in the US. Ventricular tachycardia and fibrillation are the most serious arrhythmias resulting in 300k annual US deaths, followed by 130k US deaths due to a trial fibrillation (AF). With aprevalence of 6M in the US, AF is the most common arrhythmia, resulting in 750k annual US hospitalizations.AF-associated medical costs will exceed $50B by 2035. AF therapies first rely on pharmaceuticals to preventblood clots and to restore rhythm. If these approaches fail, electrophysiology (EP) procedures are performedwhich pass electrical currents (or coolants) through the catheter's tip to destroy tissues disrupting properelectrical signals. However, manual catheters rely on complex tension-wire designs operated from a meteraway which makes effective catheter control difficult, leading to injury and AF recurrence. Robotic platforms have struggled to improve catheter control for decades. Most robotic systems manipulatestandard manual catheters; however, learning curves remain high and catheter tip control is unimproved.Magnet-based systems that use magnetic catheters improve control; however, the systems are impracticallylarge, difficult to use, and require a custom angiography suite. Because all existing robotic solutions remainprohibitively expensive, such systems are found only in a limited number of high-volume centers despite thatmore than 80% of all hospitals providing ablation are lower-volume centers. What is needed is an affordableand workflow-friendly robotic technology that improves catheter control and enables expertise within high-volume EP centers to be remotely shared with lower-volume centers for training and procedural support. UNandUP's MAP-EP (Magnetic Assistive Platform for EP) system controls novel linkage-based magneticcatheters using a magnet mass 50X smaller than previously possible. As a result, the MAP-EP system can beinstalled into existing digital angiography suites without the need for a new c-arm or room construction.Because energy is not expended fighting catheter restoring forces, low magnetic fields achieve stable,accurate, and precise heart wall contact. The technology complements standard EP workflows, is affordablefor low-volume EP centers, and provides telerobotic access to expertise within high-volume centers. In the Phase I effort, a prototype magnet workstation was constructed, novel magnetic materials weredeveloped to manufacture smaller and more complex magnets than previously possible, and prototypecatheters were successfully built and assessed using known heart phantoms. I-Corps and TABA participationwere completed, and FDA pre-submission meetings were held in support of mapping [510(k)], ablation (PMA),and Early Feasibility Studies. For the proposed effort, UNandUP will develop preclinical versions of its system.Efficacy studies will be completed using known beating heart phantoms. Biocompatibility testing and large-animal safety and feasibility studies will be conducted following published methods.

Public Health Relevance Statement:
Arrhythmias are a major cause of US mortality with ventricular fibrillation, ventricular tachycardia, and atrial fibrillation resulting in 430,000 annual deaths. Although catheter ablation is a proven treatment option, as reinforced by the HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement, control of ablation catheters can be complex, resulting in imprecise and unreliable heart-wall contact leading to an increased likelihood of injury and arrhythmia recurrence. UNandUP (short for "Unmet Needs and Underserved Populations") is developing an affordable angiosuite compatible platform which uses low magnetic fields to overcome prior limitations related to electrophysiology catheter navigational accuracy, stability, and applied forces.

Project Terms:
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