Pulmonary embolism (PE) is the third most common cause of cardiovascular death in the United States.Approximately 500,000-600,000 Americans are diagnosed with PE, which causes up to 180,000 death per year.According to the American Heart Association (AHA), PE is classified into three categories: massive, submassive,or low risk. Treatment with anticoagulants is the cornerstone for treatment of PE; however, suboptimal results suchas a similar 30-days mortality, and an ~five-fold increase in the risk of major bleeding, and a 10-fold increase in therisk of intracranial hemorrhage, compared with placebo, in patients with submassive and massive PE, and onlyone-third of unstable PE patients (30%) received recommended thrombolytic therapy even when they are eligible.These suboptimal results with anticoagulants have led to the use of other treatments such as catheter-directedtherapies (CDT). CDT includes catheter-directed thrombolysis (CDL) and catheter-based embolectomy. There aresome limitations to the use of CDL, including the risk of hemorrhage, doses are still being investigated, and theevidence for the benefits of this technology is still lacking. Despite the compelling results of mechanicalthrombectomy (MT) landmark trials, MT in PE is rarely performed. Our extensive discovery interviews amongmultiple KOLs have led us to identify the requirements of the new device to improve clinical outcomes and usabilityacceptance and establish MT as gold-standard treatment for submassive and massive PE, which include: 1) safeand smooth navigation into the PAs(<16F catheter); 2) rapid and continuous ingestion of emboli recanalizing largeand medium-size branches of the pulmonary tree (efficacy equivalent to >20F catheter); 3) directionalthrombectomy; 4) minimal blood loss; 5) negligible spillage of arrhythmogenic hemolysis byproducts. To addressthese issues, we propose to develop an entirely new class of MT devices, named Vortex Catheter Technology (V-CaTh), that augments suction catheters efficacy by a breakthrough mechanism we identified that generates apowerful whirlpool by converting the high rotational energy transmitted by a high-torque shaft into a hydrodynamicvortex. This mechanism enables the small catheter to remove large and stiff clots by progressive rotationalelongation and pulling of the clot into the catheter ("a device that is small but acts big") while preventingintravascular clot maceration and significantly reducing blood loss. We have previously completed extensivefoundational research and iterative prototyping of our device in the context of MT for stroke. In this Phase 1 SBIR,we will expand the technological platform with pivotal engineering, development, and preclinical testing of a user-specified V-CaTh system for thrombectomy in PE. In order to ensure the adequate performance of the V-CaThprototypes at key points along the development, we will carry out the following objectives: 1) user-specified designand development of the V-CaTh system and; 2) Iterative testing and optimization of the V-CaTh system inphantom PAs and human cadavers. If we achieve these Aims, E2 will be well-situated to move toward FDAsubmission, providing the interventional community with a specialized new tool to address the gap in PE care.
Public Health Relevance Statement: PROJECT NARRATIVE
While there is a wide range of therapies used to treat pulmonary embolism (PE), many barriers to ideal outcomes
remain, and a gold-standard treatment is currently undefined for intermediate to high-risk PE. In this Phase 1 SBIR
program, Endovascular Engineering Inc. (E2) proposes to develop and validate the entirely new class of
thrombectomy system (V-Cath system) that augments the efficacy of any suction catheter, including a small
catheter, to ingest emboli by the generation of a unique and powerful whirlpool. Successful achievement of the
goals of this proposal will enable E2 to be well-situated to move toward FDA submission.
Project Terms: programs ; mechanical ; Mechanics ; Debulking ; cytoreductive surgery ; surgical cytoreduction ; tumor cytoreduction ; Tumor Debulking ; System ; thrombolysis ; Best Practice Analysis ; Benchmarking ; Inferior ; American ; experience ; Performance ; success ; Speed ; Categories ; Devices ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; Bypass ; Modeling ; preventing ; prevent ; Diameter ; Caliber ; Clotting ; Coagulation ; Coagulation Process ; Address ; Dose ; Data ; pre-clinical testing ; Preclinical Testing ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Process ; Ventricular ; Development ; developmental ; community intervention ; design ; designing ; Outcome ; usability ; reconstitution ; reconstitute ; prototype ; high risk ; standard care ; standard treatment ; good laboratory practice ; Geometry ; experimental study ; experiment ; experimental research ; Achievement ; Achievement Attainment ; American Heart Association ; Anatomy ; Anatomic ; Anatomic Sites ; Anatomic structures ; Anatomical Sciences ; Anticoagulants ; Anticoagulant Agents ; Anticoagulant Drugs ; blood thinner ; thrombopoiesis inhibitor ; Arteries ; Blood ; Blood Reticuloendothelial System ; Cadaver ; Cardiovascular system ; Cardiovascular ; Cardiovascular Body System ; Cardiovascular Organ System ; Heart Vascular ; circulatory system ; Cessation of life ; Death ; Diagnosis ; Elements ; Embolism ; Embolus ; Engineering ; Equilibrium ; balance ; balance function ; Extravasation ; Leakage ; Spillage ; Feedback ; Foundations ; Glass ; Goals ; Gold ; Heart ; Hemoglobin concentration result ; hemoglobin level ; Hemolysis ; erythrolysis ; Hemorrhage ; Bleeding ; blood loss ; Human ; Modern Man ; Interview ; Lung ; Lung Respiratory System ; pulmonary ; Michigan ; Morbidity - disease rate ; Morbidity ; mortality ; Names ; Patients ; Placebos ; Sham Treatment ; sham therapy ; pressure ; Pulmonary artery structure ; Pulmonary Artery ; Pulmonary Embolism ; Recurrence ; Recurrent ; Research ; Risk ; Rotation ; Societies ; Stroke ; Apoplexy ; Brain Vascular Accident ; Cerebral Stroke ; Cerebrovascular Apoplexy ; Cerebrovascular Stroke ; brain attack ; cerebral vascular accident ; cerebrovascular accident ; Suction ; Mechanical Aspiration ; Suction Drainage ; Technology ; Testing ; Thrombolytic Therapy ; Fibrinolytic Therapy ; Therapeutic Thrombolysis ; Time ; Travel ; Trees ; United States ; Universities ; Generations ; Catheters ; Caring ; Intracranial Hemorrhages ; Embolectomy ; Thrombectomy ; Tube ; base ; Pump ; improved ; Procedures ; Clinical ; Specific qualifier value ; Specified ; Phase ; Physiological ; Physiologic ; Ensure ; Failure ; Ingestion ; analog ; Funding ; Shapes ; tool ; Venous ; Aspirate ; Aspirate substance ; Torque ;
