Blaze Medical Devices — Department of Health and Human Services SBIR Phase I: FDA

Description

DESCRIPTION provided by applicant Blaze Medical Devices Blaze is developing a rapid integrated test for RBC mechanical fragility MF as a potential indicator of safety and performance of blood handling devices The safety and performance of blood handling devices such as VADs are evaluated by hemocompatibility testing to assess the damage they inflict upon red blood cells RBC The chief indicator of this damage is the amount of hemolysis induced by a device as it interacts with the blood However hemolysis alone fails to ascertain andquot sub hemolyticandquot damage that is not cell lethal but is nevertheless important to know as it can reflect susceptibility to future hemolysis in vivo and its associated known problematic consequences The mechanical fragility MF of the RBC has been recognized in the literature as a more sensitive metric of cell damage than hemolysis alone but the lack of a standardized well accepted test for it has also been noted in the literature and even cited by medical insurers Blaze is providing the first rapid and convenient test for RBC MF via a bench top device using single use consumable cartridges for each sample The technological innovation of Blazeandapos s product includes patented means to quantify hemolysis in a sample without the need to centrifuge or otherwise separate as well as a patented approach to gathering fragility profiles via automated varying of multiple stress parameters The long term goal is to validate MFandapos s use in assessing safety and performance of blood handling devices The hypothesis for the Phase I research is that RBC mechanical fragility will reflect differences in performance between the two mechanical assist devices centrifugal LVAD HeartMate II and axial HeartWare HVAD and that further it can be used to monitor the post op performance of blood handling devices based on the correlation between RBC MF and post operative VAD implant outcomes This project aims to preliminarily validate this hypothesis on a cohort of patients scheduled for implantation of each Phase Specific Aims Validate RBC mechanical fragility MF as a potential metric of blood damage caused by implantable blood contacting devices Establish the differences in blood damage from an axial flow LVAD with bearing design Thoratec HeartMate II and a centrifugal flow LVAD with bearing less design HeartWare HVAD by RBC MF Establish the variability in blood damage caused by implantable blood contacting devices across different patients Phase II research will include larger scale follow up work both quantitatively e g sample sizes sufficient to evaluate MF changes as a predictor for thrombosis and qualitatively e g more devices tested and or stratified patient groupings for more thorough analyses PUBLIC HEALTH RELEVANCE Proposed project aims to preliminary validate in vitro Red Blood Cell membrane Mechanical Fragility MF as evaluated through MF profiles e g induced hemolysis vs applied stress duration magnitude as a candidate metric predictive of safety and performance of blood handling devices While current assessments of induced blood damage by blood handling devices rely primarily on hemolysis they do not account for possible andquot sub hemolyticandquot RBC damage which can significantly impact devicesandapos performance and thus outcomes hence the need for more andquot comprehensiveandquot assessment of induced blood damage