Peytant Solutions, Inc. Granted FDA De Novo for AMStent® Tracheobronchial Covered Stent System

PLYMOUTH, Minn., Oct. 22, 2024 /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 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 cancer. In the United States, lung cancer is the leading cause of cancer deaths, accounting for about 1 in 5 of all cancer deaths. Many patients with cancer in the lung develop malignant airway obstructions as the disease progresses. Palliative care is often pursued by increasing airflow in the trachea or tracheobronchial tree through dilation of the lumen. Once airflow is restored, it is routine to place airway stents in the passageway. The benefits of the AMStent® System, as seen in validation data, include reduced migration, reduced local inflammation and granuloma formation, and reduced mucus accumulation and occlusion – so important to achieving the desired palliative relief for the patient. "To effectively treat blockages caused by cancerous tumors, physicians require devices that maintain efficacy and reduce adverse events," said Craig M. Walker, MD, Founder, President and Medical Director of Cardiovascular Institute of the South in Houma, Louisiana and Clinical Professor of Medicine at Tulane University School of Medicine and LSU School of Medicine in New Orleans. "The AMStent® System is a unique option for patients who need it most," states Dr. Walker.

Peytant is the pioneer in the development of human amnion-based covering for stents. "We are optimistic that the AMStent® System will prove to be a much-needed option for patients suffering from tracheobronchial obstruction due to malignant tumors," said John Schorgl, Peytant Cofounder and CEO. "With the availability of the AMStent® System, we hope to improve the palliative care and thereby the quality of life for these patients."

About Peytant Solutions, Inc.
Peytant is a medical technology manufacturer seeking to improve outcomes for patients with luminal blockages. Peytant, based in Plymouth, Minnesota, is focused on commercializing the AMStent® System, a platform technology comprising an amnion-based covered stent and catheter delivery system. Peytant's AMStent® System is the first step toward transforming the treatment of luminal diseases.

SOURCE Peytant Solutions, Inc.

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