Peytant Solutions has received marketing authorisation from the US Food and Drug Administration (FDA) for its AMStent tracheobronchial covered stent system.

This novel therapy platform is indicated for adult patients suffering from tracheobronchial strictures due to malignant neoplasms.

The stent system represents the first offering within Peytant’s amnion-based covered stent platform, which combines a minimally invasive catheter delivery system with a stent covered in amnion-derived material.

Amnion began as a transplant material for eye surface reconstruction and has since been utilised to treat chronic wounds and skin ulcers.

The AMStent system has demonstrated several benefits in validation data, including reduced stent migration, less local inflammation and granuloma formation, and decreased mucus accumulation leading to occlusion.

These advantages are crucial for providing the palliative relief desired by patients with tracheobronchial obstructions due to malignancies.

The system specifically targets pulmonary obstructions caused by cancer, which is particularly significant given that lung cancer remains the leading cause of cancer deaths in the US, representing approximately one-fifth of all cancer fatalities.

Patients with lung cancer often experience malignant airway obstructions as the disease advances.

To alleviate these blockages, palliative care strategies typically involve increasing airflow through dilation of the lumen in the trachea or tracheobronchial tree.

Subsequently, airway stents are commonly placed to maintain the restored airflow. Peytant is claimed to be the pioneer in the development of human amnion-based covering for stents.

Peytant co-founder and CEO John Schorgl said: “We are optimistic that the AMStent system will prove to be a much-needed option for patients suffering from tracheobronchial obstruction due to malignant tumours.

“With the availability of the AMStent system, we hope to improve the palliative care and thereby the quality of life for these patients.”