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The AMStent® Tracheobronchial Covered Stent System (AMStent® System) is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms in adult patients.

Peytant Solutions, Inc. developed the AMStent® Tracheobronchial Covered Stent System (AMStent System) to provide patency of the tracheobronchial tree in patients suffering from tracheobronchial strictures produced by malignant neoplasms. Like other nitinol devices that are also used for treating tracheobronchial strictures produced by malignant neoplasms, the AMStent System consists of a self-expanding metallic stent (SEMS) that has a covering material over the interstices of the stent is provided preloaded on a delivery catheter (Figure 1). The difference is that the AMStent covering is made from human-sourced decellularized amniotic membrane (DCAM), while the existing stents utilize synthetic cover materials (e.g., polyurethane, ePTFE, or silicone). The AMStent is an open-cell, self-expanding, nitinol stent (10mm diameter x 40mm length) with a DCAM cover that is attached to the stent with polyethylene terephthalate (PET) sutures. The AMStent is preloaded on a flexible, "pull-back," AMStent delivery catheter. The AMStent delivery catheter is positioned in the tracheobronchial stricture with the assistance of a standard 0.035" guidewire, that is not provided with the AMStent System, under bronchoscopic and / or fluoroscopic visualization. Radiopaque markers are located on each end of the AMStent and on the distal end of the AMStent delivery catheter to facilitate placement.