Research Project
9546835
? DESCRIPTION (provided by applicant): Significance: Pediatric patients with pulmonary artery stenosis face treatment options with significant limitations. For example, metal stents are limited by long-term interference with natural vessel growth. Patients implanted with metal stents are subject to multiple hospital admissions for interventional stent expansions, often requiring fracture of the stent and open- heart surgery for removal. As such, there is an emergent need for pediatric-specific devices for this underserved population. Approach: In response to a solicitation from NHLBI, 480 Biomedical developed a self- expanding, bioresorbable stent to treat pulmonary artery stenosis under a Fast-Track SBIR. Through the Fast-Track project, promising animal results were achieved through the device resorption period, while in growing vessels. On the strength of these Fast-Track data, we raised $1.2M of funding from Broadview Ventures. This Phase IIB SBIR application will enable advancement of this product towards commercialization application. In this project, first-in- human experience with this innovative device will be achieved. During Year 1, current bench and animal data will be supplemented to create a data package to enable submission of an Investigational Device Exemption (IDE) for an Early Feasibility Study (EFS). This accomplishment will enable enrollment of clinical subjects during Year 2. Year 3 will be focused on 12mo follow-up in the EFS, and along with an extensive package of bench and pre-clinical data, this human data will be submitted to the FDA for marketing clearance. This project represents an important step in the commercialization of a therapy that has the potential to be a game-changer for pediatric patients with pulmonary artery stenosis. Innovation: 480 Biomedical's novel stent couples full bioresorption with self-expansion: two features that are ideal for the pediatric population. This combination of properties is achieved through our unique composite design. By utilizing a strong base braid coated with a proprietary elastomer, we can achieve properties that are similar to metal in a fully resorbable design. The self-expansion of this design provides the added benefit of enabling the stent to maintain apposition with the vessel wall as a pediatric patient grows. The fast, yet safe, resorption characteristics of the design will enable the device to grow with the vessel without impeding early intervention, if required.
