Development of a sutureless LVAD outflow graft anastomotic quick-connect system

Heart failureHFis the leading cause of death in the United Statesaffecting nearly six million people at a cost over $billionClinically approved mechanical circulatory supportMCStherapysuch as left ventricular assist devicesLVADscontinue to improve as a viable treatment option for patients with advanced heart failure as evidenced by overimplants over the past five yearsHoweverMCS device therapy can be surgically invasivetime consumingprone to adverse eventsand often requires a median sternotomycardiopulmonary bypassCPBand partial clampingcross clampingof the aorta to facilitate anastomosis of the outflow graftThese procedures are associated with adverse events including risk of post operative infectionbleedingpulmonary complicationspost operative neurological complicationsand potential aortic dissectionConventional manual suturing techniques are currently used to attach a MCS device outflow graft to the ascending aortaand for which CPB support and aortic clamping time may increase risk of post operative adverse eventsTo improve clinical outcomesMASTLouisvilleKYis developing a sutureless anastomotic graft connection devicesG Ato eliminate the need for manual suturing and CPB during MCS device surgerySeveral sutureless vascular connection devices have been proposed and or developedhowevermost of these devices were designed for smaller graft and vessel sizesandltmm diameterthat are primarily used for coronary artery bypass graftCABGproceduresMany surgical adhesives have also been proposed and or developed as an alternative to suturing techniques for achieving vascular connection and hemostatic sealingbut have not achieved clinical acceptance due to poor strength and toxicity concernsThe MAST sG A system is unique in that it is designed to attach large diameter graftsmm diameterto large vesselsmm diameterusing a hybrid polymer mechanical seal to achieve hemostasisThe sG A device is a nitinol winged connector attached to the distal end of an outflow graft and an external polymer flanged cuff that covers the end to side intersection of the aortotomy and outflow graftThe super elastic properties of annealed nitinol allow for the winged connector to be deformed and compressed for loading into the delivery aortotomy tooland restored to its functional shape when deployedpotentially enabling distal graft anastomosis via a lessinvasive surgical approachIn this SBIR phase I proposalwe will demonstrate feasibility of the sG A systemand then plan to submit a phase II proposal to complete engineering development to achieve a design freeze of the sG A system and complete pre clinical testing to demonstrate efficacysafetyand reliabilityThe phase II experimental data will be used to support an Investigational Device ExemptionIDEapplication to the Food and Drug AdministrationFDAfor clinical trials Investigators at MASTLouisvilleKYand the University of LouisvilleUofLare developing a sutureless graft to aortasG Aanastomotic device to facilitate minimally invasive surgery for implant of mechanical circulatory supportMCSdevicesThe sG A system will enable surgeons to connect the MCS device outflow graft more efficientlywhich should result in shorter procedures with improved patient outcomes and better quality of life