Transcatheter Device for Congestive Heart Failure Treatment Through Left Atrial Decompression

Project Summary Abstract DescriptionCongestive heart failureCHFis a chronic and progressive condition that currently affects overmillion patients in the USIt accounts for over $B in direct healthcare expenditure and over one million hospitalizations each yearPatients exhibit shortness of breathdecreased exercise tolerance and overall reduced quality of lifeDespite best medical therapythe prognosis of CHF remains pooryear andyear mortality rates areandrespectivelyPatients with CHF have progressive dysfunction of their heart musclewhich limits its ability to eject blood out of the heartAs the heart failspressure builds up in the left atrium and this pressure backs up further into the pulmonary circulation leading to pulmonary fluid accumulation and its associated symptomsRecentlythe concept of interatrial shunting has gained attention as a potential therapeutic option for patients with CHFBy creating a connection between the high pressure left atrium to the low pressure right atriumelevated left atrial pressureLAPmay be effectively loweredthereby relieving CHF symptomsTwo early stage companies have developed interatrial stents to create such a shunt and have shown improved quality of life and increased exercise tolerance at one yearNonethelessintracardiac implants carry proven clinical risks including clot formationdevice fracture and implantation failureAlleviant Medical is developing a novel minimally invasive medical devicethe Left Atrial Decompression SystemLADSthat creates a precise interatrial shunt without a cardiac implantUnder fluoroscopic guidance in the catheterization labthe LADS is intended to excise and safely remove a portion of the interatrial septumthereby creating a therapeutic interatrial shunt with long term patencyThe current stage of the LADS is a working prototype that successfully cuts and captures tissue in an ex vivo porcine heartThe proposed SBIR grant establishes a clear plan to move from working design to a fully functional prototype that demonstrates success in vivo and affords LAP reduction in a porcine elevated LAPe LAPmodelIn Specific Aimtwo key components of the LADSblade and tensionerwill be optimized and the full system will be used to demonstrate reproducible shunt creation on ex vivo porcine hearts and successful deployment in vivo in an acute porcine modelIn Specific Aimthe fully functional LADS will be used to evaluate LAP reduction in vivo in an acutee LAPporcine modelSuccessful completion of the work outlined in this proposal will result in a fully functional LADS capable of reproducibly creating an interatrial shunt in vivoand which demonstrates LAP reduction in an e LAP animal modelFurther workto be detailed in a subsequent Phase II grant applicationwill seek to finalize LADS design in compliance with FDA design controlscomplete product verification and validationand demonstrate safety through a statistically powered chronic animal studyas required to obtain FDAkclearance as a Class II medical device Project Narrative Public Health RelevanceCongestive heart failure is a chronic and progressive condition that currently affects overmillion patients in the US and poses a major public health burdenSymptoms of the disease are duein large partto elevated left atrial pressurewhich results from failure of the heart to adequately eject blood from its main pumping chamberleft ventricleThe proposed project seeks to develop a novel medical device that effectively lowers left atrial pressure through a simplelow riskminimally invasive procedure and thereby reduce the symptoms and morbidity associated with the disease