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Pediatric heart valve disease affects children worldwide and necessitates valve replacements that remodel and grow with the patient. Current valve manufacturing technologies struggle to create valves that facilitate native tissue remodeling for permanent replacements. Here, we present focused rotary jet spinning (FRJS) for implantable medical devices, such as heart valves, to address this challenge. Combining RJS and a focused air stream, FRJS prints FibraValves, micro- and nanofibrous heart valves, in minutes. The micro- and nanoscale features provide structural cues to orient cells at the biotic-abiotic interface, while the centimeter-scale valve shape regulates cardiac flow. We built valves using poly(L-lactide-co-Ɛ-caprolactone) fiber scaffolds, which supported rapid cellular infiltration and displayed native valve-like mechanical properties. Evaluating clinical translatability, we assessed acute performance in a large animal model using a transcatheter delivery approach. These tests indicate that FRJS is a viable method for manufacturing heart valves and future medical implants. 

Helical alignments within the heart’s musculature have been speculated to be important in achieving physiological pumping efficiencies. Testing this possibility is difficult, however, because it is challenging to reproduce the fine spatial features and complex structures of the heart’s musculature using current techniques. Here we report focused rotary jet spinning (FRJS), an additive manufacturing approach that enables rapid fabrication of micro/nanofiber scaffolds with programmable alignments in three-dimensional geometries. Seeding these scaffolds with cardiomyocytes enabled the biofabrication of tissue-engineered ventricles, with helically aligned models displaying more uniform deformations, greater apical shortening, and increased ejection fractions compared with circumferential alignments. The ability of FRJS to control fiber arrangements in three dimensions offers a streamlined approach to fabricating tissues and organs, with this work demonstrating how helical architectures contribute to cardiac performance.