Novel Self-closing 12F Mitral Valve Repair System to Percutaneously Treat Moderate to Severe Regurgitation Using Transcatheter Edge-to-Edge Repair (TEER) Technique Via Femoral Vein Access.

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Principal Investigator: Raghuveer  Basude
Organization: MEDFREE, INC.
Fiscal Year: 2024
Award: $275,530
Funding agency: National Heart Lung and Blood Institute

Project Summary
The MEDFREE® Valve Repair System will innovatively improve upon the current market leading MitraClip
device, while leveraging and building on the proven Transcatheter Edge-to-Edge Repair technique. We aim to
address this vastly unmet percutaneous structural heart market by delivering a simpler, easier-to-use device in
a smaller 12F catheter system that can be used by a single operator. MEDFREE has already completed
preclinical GLP studies in porcine model (Cohort A: n=2, 30 days; Cohort B: n=5, 140 days) with outstanding
results. MRI and Durability (fatigue) studies were also completed with outstanding results. We are now seeking
funds via NIH Commercialization Readiness Program, in preparation for EFS/FIH clinical studies.

Terms: <Address><Affect><Anatomic Models><Anatomical Models><Animals><Bicuspid Valve><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 affected><COVID-19 consequence><COVID-19 crisis><COVID-19 effect><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 impact><COVID-19 impacted><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Catheters><Cessation of life><Clinical><Clinical Research><Clinical Study><Clinical Trials Data Monitoring Committees><Contracting Opportunities><Contracts><Data><Data Monitoring Committees><Data and Safety Monitoring Boards><Death><Development and Research><Devices><Documentation><Equipment and supply inventories><Evaluation><FDA approved><Fatigue><Feasibility Studies><Femoral vein><Freezing><Funding><Goals><Government><Heart><Human><IRB><IRBs><Individual><Informed Consent><Institutional Review Boards><Intervention><Intervention Strategies><Inventory><Investigation><Lack of Energy><Length><MR Imaging><MR Tomography><MRI><MRIs><Magnetic Resonance Imaging><Marketing><Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance><Mitral Incompetence><Mitral Insufficiency><Mitral Regurgitation><Mitral Valve><Mitral Valve Incompetence><Mitral Valve Insufficiency><Mitral Valve Regurgitation><Modern Man><Monitor><NIH><NMR Imaging><NMR Tomography><National Institutes of Health><Newly Diagnosed><Notification><Nuclear Magnetic Resonance Imaging><Operative Procedures><Operative Surgical Procedures><Patients><Persons><Phase><Physicians><Population><Preparation><Procedures><Process><Protocol><Protocols documentation><R & D><R&D><Reporting><Research Contracts><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Safety Monitoring Boards><Sample Size><Secure><Septal Vein><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Site><Surgical><Surgical Interventions><Surgical Procedure><System><Techniques><Technology><Testing><United States><United States National Institutes of Health><Writing><Zeugmatography><co-morbid><co-morbidity><cohort><commercialization><commercialization readiness><comorbidity><coronavirus disease 2019 consequence><coronavirus disease 2019 crisis><coronavirus disease 2019 effect><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 impact><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 impact><coronavirus disease-19 pandemic><cost><design><design validation><design verification><designing><frailty><high risk><improved><in vitro Model><in vitro testing><innovate><innovation><innovative><interventional strategy><manufacture><meeting><meetings><new technology><novel><novel technologies><pig model><piglet model><porcine model><post-COVID><post-COVID-19><post-coronavirus disease 2019><pre-clinical><preclinical><preparations><programs><prototype><public health relevance><repair><repaired><research and development><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><surgery><swine model>