Development of a new dedicated bridging stent for FEVAR: initial ideas, design and testing, on-label approval, and...

The aim of this review was to describe the complete development of the BeFlared (Bentley Innomed, Hechingen, Germany), a bridging stent specifically designed for fenestrated endovascular aneurysm repair (FEVAR). Most balloon-expandable covered stents used as bridging stent were developed for other vascular territories and have been employed off-label in FEVAR. Their implantation requires a two-step deployment with a flaring sequence, which increases procedural complexity, and may be responsible for peri-operative complications. To address these limitations, the BeFlared stent was conceived as a balloon-expandable covered stent incorporating a balloon enabling single-step deployment and flaring. Preclinical evaluation of the BeFlared started with the development of a purpose-built pararenal aneurysm model in swine, as previously available models were not suitable for FEVAR. A controlled perfused patient-specific three-dimensional printed platform simulating physiologic flow and complex anatomy was developed for an in vitro trial, and allowed for the replication of the diversity and complexity of clinical anatomies. These complementary investigations demonstrated the functional equivalence between the BeFlared and the reference device (BeGraft) with respect to sealing and positioning, while confirming reproducible flaring configuration. The collected preclinical data supported CE-mark approval following European regulatory framework. Early clinical experience indicates safety and performance comparable to conventional balloon-expandable covered stents, with potential reduction in procedure duration and radiation exposure. The translational pathway of the BeFlared stent illustrates how innovation, structured preclinical validation and collaboration between engineers and physicians may accelerate innovation in complex endovascular repair.