SBIR-STTR Award

This Phase I STTR application from Caeli Vascular, LLC entails a 12-month period focused on the development of a novel endovascular venous thrombectomy device. The PI is a vascular surgeon with biomedical research and entrepreneurship experience, and is supported by a team of highly qualified investigators, including a vascular biologist, neurosurgeon, veterinarian, biomedical engineer, mechanical engineer, and a marketing and management expert. The primary objective of this application is to test a catheter-based venous thrombectomy device designed to address all current gaps in the state of the art for the treatment of large volume deep venous thrombus (DVT) in the inferior vena cava (IVC) and iliac veins (iliocaval venous segment). Each year, more than 900,000 Americans will develop a large-volume DVT. As many as 100,000 will die as a result of a complication within 2 weeks of diagnosis. Approximately 50% of patients with large-volume acute DVT will develop a severe complication such as fatal pulmonary emboli (PE). Treatment options of large volume DVT in the iliocaval venous segment are limited, and currently available percutaneous endovascular thrombectomy devices have various shortcomings that affect treatment efficacy and safety. Major gaps include increased risk of intra-procedural thrombus embolization leading to PE, poor thrombolytic penetration leading to increased bleeding risk, and inability to completely remove thrombus leading to unresolved DVT. To address all the gaps in the state of the art of percutaneous venous thrombectomy devices we designed and prototyped the Hydra Catheter. Unique and proprietary features of the Hydra Catheter include adjustable ecapsulation balloons, an infusion catheter segment to facilitate delivery of thrombolytics and isovolumetric infusion/suction, and a built-in leaflet agitator. Our preliminary findings demonstrated high efficacy compared to current FDA- approved mechanical suction thrombectomy catheters. Our multi-disciplinary team of investigators proposes to test feasibility of the Hydra Catheter prototype in an ex vivo vena cava flow model in the following clinically- relevant specific aims: Aim I: Confirm that Hydra catheter adjustable balloon encapsulation design eliminates embolization of distal thrombus fragments. Aim II: Demonstrate that isovolumetric suction can clear a venous ‘treatment zone’ without risk of venous wall collapse and distension damage. Aim III: Determine whether Hydra Catheter leaflet agitator increases blood clot fragmentation and grasping. By completing these proposed aims we will establish the mechanical feasibility of the novel Hydra catheter prototype for the treatment of large-volume iliocaval DVT. These findings will allow us to prepare Phase II pre- commercialization studies necessary for FDA-regulatory clearance through an anticipated 510(k) mechanism based on predicate devices designed for either mechanical or chemical thrombectomy.

Public Health Relevance Statement:
PROJECT NARRATIVE / PUBLIC HEALTH STATEMENT Over the last two decades deep venous thrombosis (DVT) has become a national and international health concern that affects at least 700 per 100,000 individuals, and leads to 60,000-100,000 deaths per year. Currently there are significant limitations associated with existing devices for the treatment of DVTs, and no devices tailored for the treatment of large-volume DVTs in the vena cava and iliac veins of the abdomen and pelvis. We developed the Hydra Catheter, which is a novel endoluminal device that synergies the use of adjustable balloon encapsulation, isovolumetric clot flushing, and chemical and mechanical clot fragmentation techniques. This proposal will focus on the feasibility testing of this device in an ex vivo system in preparation for potential future in vivo and human testing.

Project Terms:
Abdomen; Acute; Address; Affect; Age; American; Anticoagulation; base; Biomedical Engineering; Biomedical Research; Blood coagulation; Blood Vessels; Boston; Caliber; Catheters; Cessation of life; Chemicals; Clinical Trials; clinically relevant; clinically significant; Coagulation Process; Collaborations; commercial application; commercialization; comparative efficacy; Complication; Data; Deep Vein Thrombosis; design; Development; Device Designs; Device Removal; Devices; Diagnosis; Distal; effective therapy; Elements; Embolism; Engineering; Ensure; Entrepreneurship; Excision; experience; FDA approved; Flushing; Future; Goals; grasp; Health; Hemorrhage; Hospitals; Human; Iliac Vein; improved; in vivo; Incidence; Individual; individualized medicine; Inferior vena cava structure; Infusion procedures; innovation; International; Knowledge; Lung; Marketing; Mechanics; Medical Device; medical schools; minimally invasive; Modeling; Molds; Morbidity - disease rate; multidisciplinary; multimodality; Neurosurgeon; novel; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Pelvis; Penetration; Phase; Plastics; Population; Preparation; pressure; prevent; procedure cost; Procedures; Proteins; prototype; Public Health; Research Personnel; Risk; Safety; simulation; Small Business Technology Transfer Research; Smooth Muscle; Source; standard of care; Suction; Surgeon; synergism; System; Techniques; Testing; Therapeutic; Therapeutic Embolization; Thrombectomy; thrombolysis; Thrombus; Treatment Efficacy; Universities; Vacuum; Veins; Vena caval structure; Venous; Venous system; Venus; Veterinarians; Washington

This Phase II STTR application from Caeli Vascular, LLC entails a 24-month period focused on furtherdevelopment of a novel multi-modal venous thrombectomy device. The PI is a vascular surgeon withbiomedical research and entrepreneurship experience, and is supported by a team of highly qualifiedinvestigators, including a vascular biologist, neurosurgeon, veterinarian, biomedical engineer, mechanicalengineer, and a team of marketing and management experts. The primary objective of this application is tobuild on successful Phase I feasibility studies, and further develop the Hydra Catheter Thrombectomy Systemtechnology to address all current gaps in the state of the art for the treatment of large-volume deep venousthrombus (DVT). Each year, more than 900,000 Americans will develop a large-volume DVT, and up to 100,000 of these willdie as a result of a complication within 2 weeks of diagnosis. Treatment options of large-volume DVT arelimited, and currently available percutaneous endovascular thrombectomy devices have various shortcomingsthat impact treatment efficacy and safety. Major gaps include increased risk of intra-procedural thrombusembolization leading to a pulmonary embolus (PE), systemic leak of chemical thrombolytic medication leadingto increased risk of bleeding, risk of vein wall and valve trauma leading to chronic impairments, and inability tocompletely remove thrombus leading to unresolved DVT. To address all the gaps in the state of the art ofpercutaneous venous thrombectomy devices we designed and prototyped the Hydra Catheter ThrombectomySystem. Unique and proprietary features of the device include adjustable ecapsulation balloons, an infusioncatheter segment to facilitate localized and judicious delivery of chemical thrombolytics, a rail-mounted leafletagitator that does not engage the vein wall, and mechanism for isovolumetric suction and infusion to facilitateflushing of thrombus fragments and thrombolytics from the venous treatment zone. Phase I studiesdemonstrated the feasibility of the device to prevent distal microembolization, prevent vein wall collapse andover-distension, and achieve effective removal of luminal thrombus in an ex vivo flow system. In this Phase IIstudy, our team will further develop key component of the device and evaluate the efficiency of the technologyex vivo and in vivo with the following specific aims: Aim 1: Develop and test a newer generation Hydra Pump to facilitate isovolumetric suction and infusionthrough the Hydra Catheter Thrombectomy System in an ex vivo flow system. Aim 2: Evaluate Hydra Catheter Thrombectomy System efficacy and preliminary safety in a validated invivo porcine vena cava DVT model By completing these proposed aims we will be able to achieve the design specifications and GoodLaboratory Practice (GLP) animal studies that are required for FDA 510(k) device application submission.

Public Health Relevance Statement:
PROJECT NARRATIVE / PUBLIC HEALTH STATEMENT Over the last two decades deep venous thrombosis (DVT) has become a national and international health concern that impacts at least 700 per 100,000 individuals, and leads to 60,000-100,000 deaths per year. Currently there are significant limitations with existing devices for the treatment of large-volume DVTs. Caeli Vascular developed the Hydra Catheter Thrombectomy System, which is a novel device that synergies the use of adjustable balloon encapsulation, clot flushing, and chemical and mechanical clot fragmentation techniques. Our device will offer patients an efficient, safer, and more cost effective method for treatment of DVT - and has the potential of saving many lives.

Project Terms: