Cor Habere Corp. — Department of Health and Human Services SBIR Phase I: R

Description

In the USthere aremillion patients with nonvalvular atrial fibrillationNVAFwhich is expected to increase tomillion byThe treatment of NVAF is estimated to cost $billionincluding $billionfor hospitalizations aloneThe most significant morbidity and mortality associated with NVAF is embolic strokewithof thrombus originating from the left atrial appendageLAAAnticoagulation is the preferred treatment for NVAF patientsbut clinical studies have demonstrated high levels of non compliance and increased risk of bleeding or ineligibility for anticoagulation therapyespecially in the elderly population where the incidence of NVAF is highestCurrentlythere are multiple clinically approved surgical and catheter based LAA devicesbut they continue to be plagued by peri device leaks and thrombus formation because of residual volumesubsequently they have failed to eliminate the risk of strokeTo overcome these limitationsCor HabereLouisvilleKYand the University of Louisville are developing a LAA closure device with catheterbased deliveryStrokeShield systemthat completely occludes and collapses the LAA to minimize the risk of strokeThe StrokeShield device is a collapsible occludernitinol reinforced membranethat completely covers the LAA orifice with an expandable conical coil anchor that attaches to the outer wall of the LAAThe device is delivered using a catheter based approach and expands to completely occlude the LAA orifice and collapse the LAAThe primary advantages of the StrokeShield system are a completely sealed LAAno peri device flow or residual spaceand smooth endothelialized connection to the left atrial wall with minimal risk of cardiac bleeding and tamponadeIn this SBIR phase I proposalwe will complete testing of the StrokeShield system to achieve required sample size to demonstrate feasibilityUpon successful demonstration of feasibilitywe plan to submit a phase II proposal to complete engineering development and achieve a design freeze of the StrokeShield system by testing in human and canine models to demonstrate functional performancereliability and hemocompatibility by completing Verification and ValidationVandamp Vtesting in compliance with Good Manufacturing PracticesGMPand safety and biocompatibility by completing aday chronic study in a canine model in compliance with Good Laboratory PracticesGLPThe phase II experimental data will be used to support an Investigational Device ExemptionIDEapplication to the Food and Drug AdministrationFDAfor clinical trials in NVAF patients at risk for stroke Cor HabereLouisvilleKYand the University of Louisville are developing a left atrial appendageLAAdevice and catheter based delivery system designed to completely occlude the LAA orifice and collapse the LAA to prevent stroke in patients with nonvalvular atrial fibrillationNVAFThe StrokeShield system is designed to overcome many of the limitations associated with current pharmacologicalnon compliancebleedingand implanted devicesthrombusto improve patient outcomes and restore quality of life