Vention’s in-house design team explored various concepts and materials to design the “dog bone” balloon geometry the customer had envisioned, with Design for Manufacturability (DFM) in mind.
Leveraging Vention’s balloon-blowing capabilities, the team first fabricated a PET balloon. However, preclinical studies showed that the PET balloons were susceptible to premature burst when inflated in valves with calcification. The team repeated the study with nylon balloons, which showed better resistance to premature burst when inflated in calcified valves.
Working closely with the customer, Vention managed the processes of verification and validation, clinical and pilot manufacturing, and commercial manufacturing.