SBIR TOPIC 108, FAST-TRACK - DEVICE SYSTEM FOR TRANSCATHETER REPAIR OF POSTINFARCTION VENTRICULAR SEPTAL DEFECT

Small Business Innovation Research (SBIR) Topic 108, Device System for Transcatheter Repair of Postinfarction Ventricular Septal Defect, was advertised in Program Solicitation PHS 2019-1. Postinfarction ventricular septal defect (VSD) is an uncommon but devastating mechanical complication of acute myocardial infarction with extremely high mortality.Patients already suffering myocardial dysfunction usually die from acute volume overload superimposed on cardiogenic shock.Surgical repair confers an unacceptably high mortality, and the sole nitinol occluder device currently available under Humanitarian Device Exemption (St Jude Amplatzer Muscular VSD occluder) is highly unsatisfactory (too small, too rigid, too permeable, wrong geometry) and usually unsuccessful.There is a clear need for a purpose-built device to achieve early occlusion of postinfarction VSD, which could be lifesaving in approximately 2 - 2,000 patients annually.This market size is too small for the large medical device manufacturers to address, but fortunately is suitable for Humanitarian Device Exemption regulatory pathway.Under Phase II, the work will include mechanical and safety testing and regulatory development for the postinfarction VSD occluder device to eventually be used in human investigation.