FREEFLOW MEDICAL DEVICES LLC — Department of Health and Human Services SBIR Phase I: 300

Description

PROJECT SUMMARY Approximatelyof patients beginning hemodialysisHDin the United States use a catheter at treatment initiationandof all HD patients were using a catheter inHoweverthe use of tunneled catheters for HD vascular access is associated with a relatively high incidence of complications such as poor flow and catheter dysfunctionwith a catheter dysfunction rate ofepisodescatheter daysThe most common catheter related problems are infectionscatheter related bloodstream infectionsCRBSIand catheter thrombosisCatheter dysfunction due to intraluminal thrombosis and fibrin sheath formation impairs the delivery of adequate dialysis and often requires salvage by instillation of a thrombolytic agent into the catheter lumen and or catheter exchangeIt leads to significant morbidity of the limbs involvedincluding pulmonary embolismand post thrombotic syndromeInfections can be caused by biofouling and biofilm formationrates vary fromtopercatheter dayswhich results in significant morbidityCRBSI can result in serious complications such as spine abscessendocarditisand deathCRBSI frequently requires hospitalization and sometimes even ICU staysHoweverno available solutions to prevent catheter dysfunction can successfully prevent both thrombosis and infectionFFMD has developed a coating technology to create a tethered liquid perfluorocarbonTLPsurface that reduces the complication rate with catheter use during HD by ameliorating thrombosisbiofilm formationand infectionsIn a two step processa thin layer of perfluorocarbon is chemically bound and tethered to the surface of the HD catheter and is then is coated with a mobile thin layer of liquid perfluorocarbon to yield a super repellent TLP coatingSlippery perfluorocarbon coatings are unique because they remain stable under the clinically relevant blood flow seen in catheters and dialysis machinesresist thrombosisand prevent biofoulingThe objective of this phase I proposal is to obtain proof of concept that our TLP coating could reduce thrombogenicity and prevent biofilm formation in HD cathetersOnce proof of concept has been obtainedwe will progress to a Phase II application for cGMP manufacturing and FDA recommended biocompatibility testing ready for premarket approvalOur goal is to improve patient outcomes by enhancing the long term patency of HD catheters by reducing thrombosis and complications associated with CRBSI NARRATIVE Many patients undergoing hemodialysis require use of a catheter to secure vascular accessbut complication rates are high due to infections and thrombosishoweverno available solutions successfully prevent both these complicationsWe developed a coating technology to reduce the complication rate with catheter use during hemodialysis by ameliorating thrombosis and infectionsOur goal is to improve patient outcomes by enhancing the long term patency of HD catheters by reducing complications