Of the 4 million babies born in the US each year, 120,000 (3%) have a complex birth defect. Some defects, such as spina bifida, warrant in utero interventions to improve fetal outcomes. Spina bifida is a condition where there is incomplete closing of the backbone and membranes around the spinal cord. Texas Children?s Hospital has pioneered a fetoscopic method to address spina bifida. While much of the surgery can be performed through ports, the uterus currently needs to be exteriorized in order to position the fetus appropriately and place sutures to anchor the chorioamniotic membranes to the uterine wall. The sutures are placed to prevent preterm premature rupture of membranes (PPROM) which leads to both maternal and fetal complications. PPROM is a common complication of fetal surgery, occurring in about 30% of minimally invasive cases. The ChorioAnchor device is a linear device that facilitates the percutaneous suturing of chorioamniotic membranes to the uterine wall during fetoscopic surgery via a resorbable anchor-suture set. This solution facilitates the conversion of existing open fetal procedures to percutaneous procedures and potentially the development of new fetal interventions. There are two major unanticipated additional activities that are necessary to advance the development of ChorioAnchor towards an FDA premarket submission. This includes the development of an essential safety feature identified by clinical stakeholders during usability tests. In addition, it will be beneficial to bolster our team by expanding upon the roles of and adding subject-matter experts to assist in data analysis and path-to-market decisions. The SBIR Phase II Administrative Supplement Activities are: 1. Data Preparation for Presubmission Meeting and HDE Submission, aided by the addition of subject- matter experts in biocompatibility, toxicology, and resorbable polymer implant manufacturing to the team. 2. Addition of Tenting and Flushing Safety Features, including concept generation, prototype design, usability and risk assessment, and manufacturing. The expected outcome of the SBIR Phase II Administrative Supplement will be an updated ChorioAnchor device design with added safety mechanisms and data-driven risk mitigations to present to the FDA. We believe that the ChorioAnchor will bring value to patients, providers, and children?s hospitals by providing a solution that reduces maternal and fetal complications, expands the patient population through the development of a safer percutaneous procedure, and leads to better outcomes for babies with all manners of fetal conditions.
Administrative Supplement Narrative Preterm premature rupture of membranes is a major complication occurring in about 30% of minimally invasive fetal surgery cases to repair fetal defects. The ChorioAnchor device allows for the percutaneous deployment of an anchor-suture system, thus aiming to improve maternal outcomes through a safer procedure while preventing membrane rupture. The SBIR Phase II administrative supplement will facilitate improved data analysis and the development of essential safety features recommended by fetal surgeon collaborators in preparation for regulatory filing as a Humanitarian Device Exemption (HDE) device.
