Resilience Fully Covered Esophageal Stent System

The Resilience Fully Covered Esophageal Stent System is a self-expanding nitinol stent with a silicone covering, delivered through a scope via a 10.5F catheter. It is intended to maintain esophageal patency in patients with strictures caused by malignant tumors and to occlude esophageal fistulae.

The Resilience stent uses a 10.5F delivery catheter versus the predicate's larger 18.3F catheter. It comes in nine sizes with three lengths (5cm, 6cm, 7cm) and three midbody diameters (14mm, 17mm, 20mm). The stent design includes wider flared ends (24, 27, 28 mm depending on midbody diameter) for anchoring and migration resistance, and is supplied sterile with differences from the predicate EndoMAX stent.

ISO 10993-1 for biocompatibility testing (biological evaluation of medical devices with risk management). FDA guidance on testing and labeling devices for safety in magnetic resonance (MR) environments.

Both devices are self-expanding nitinol stents with silicone coverings intended for the identical indications: maintaining esophageal patency in malignant strictures and occluding fistulae. The Resilience stent demonstrates substantial equivalence through comprehensive non-clinical testing covering stent performance (dimensions, suture integrity, removal forces, radial pressure), delivery system functionality (deployment accuracy, repositioning), and biocompatibility. Although the Resilience catheter is smaller (10.5F vs 18.3F) and stent geometry differs slightly, these represent design improvements rather than fundamental performance changes. All testing met predetermined specifications and the device performs the same intended function as the predicate.