Functional Single Ventricle (FSV) is a life-threatening and debilitating disease associated with high morbidity and mortality. There is a birth incidence of 4 to 8 children born with FSV per 10,000, or approximately 2,300 children born with FSV per year in the United States. While surgical procedures have improved survival of patients with FSV, completion of these surgeries marks the beginning of life-long care regimes. Infants who undergo surgical procedures require frequent medical attention in the form of physician visits, regular medication use, cardiac catheterization procedures, and even additional open-heart surgeries. Hospitalizations for these patients are multiple, lengthy, and expensive. The alternative to this sequence of surgeries, is a high-risk heart transplantation which has its own significant limitations.
Worldwide congenital heart disease (CHD) management is migrating toward minimally invasive therapy. There are no purpose-built, US FDA approved, commercial transcatheter solutions for this application. In this context, there is considerable unmet clinical need for less invasive alternatives to treat children born with Functional Single Ventricle (FSV), a group of congenital heart defects (CHD).
Transcatheter Cavopulmonary Bypass Endograft Device
Transmural Systems’ Transcatheter Cavopulmonary Bypass Endograft (TCBE) device is the first and only purpose-built transcatheter system that treats FSV by creating a Bi-directional Glenn (BDG) shunt between the Superior Vena Cava (SVC) and the Pulmonary Arteries (PAs). The TCBE device would replicate and replace current clinical standard-of-care open-heart surgery. This non-surgical therapy offers an alternative to the Norwood, Bi-directional Glenn and Fontan procedures limiting the burden of surgery for infants and substantially reducing healthcare costs. We have an ongoing commitment to pediatric and orphan applications through a longstanding relationship with NHLBI Lederman Lab and Rady Children's Hospital (San Diego).