The AMStent® Tracheobronchial Covered Stent System (AMStent System) is a tracheal prothesis with cover material derived from human sources. The AMStent System is a single use tracheobronchial prosthesis used to establish patency of the tracheobronchial tree. The AMStent System components include the implantable AMStent preloaded on a single-use AMStent delivery catheter. The AMStent System contains tissue contacting components, implantable components, and is provided sterile for single use in a professional healthcare facility. There are no electrical components, and the AMStent System is not intended to be marketed with multiple system / kit components or accessories.
A non-bioabsorbable tubular device, which includes human-derived materials, intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency, to treat tracheobronchial strictures (e.g., produced by malignant neoplasms). It is in the form of a metal mesh covered by a decellularized human-derived membrane, and is typically expandable in situ (e.g., with a balloon catheter or self-expandable); disposable devices intended to assist implantation may be included with the stent.
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