Peytant Solutions, Inc. Granted FDA De Novo for AMStent Tracheobronchial Covered Stent System | PR Newswire [Video]

, /PRNewswire/ — Peytant Solutions, Inc. (Peytant) today announced that the U.S. Food and Drug Administration (FDA) granted marketing authorization (clearance to market in the United States as a Class II device) for the AMStent® Tracheobronchial Covered Stent System, a novel, proprietary therapy platform. The AMStent® System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms in adult patients.

The AMStent System® is designed to treat pulmonary obstructions caused by cancer.

The AMStent® System is the first product offering within Peytant’s amnion-based covered stent platform. The system combines a minimally invasive catheter delivery system with a stent covered in a material created from amnion. Amnion has more than 100 years of clinical history, first as a transplant for eye surface reconstruction, and more recently as a therapeutic membrane for the treatment of chronic wounds and skin ulcers.

The AMStent System® is designed to treat pulmonary obstructions caused by …