The FDA granted marketing authorization for Peytant Solutions’ AMStent tracheobronchial covered stent system. Plymouth, Minnesota-based Peytant designed its AMStent to treat pulmonary obstructions caused by cancer. The novel, proprietary therapy platform is indicated for treating tracheobronchial strictures produced by malignant neoplasms in adult patients.
The company developed AMStent as the first product offering within its amnion-based covered stent platform. It combines a minimally invasive catheter delivery system with a stent covered in material created from amnion.
Related: FDA clears Gentuity imaging system for coronary interventions
According to Peytant, many patients with cancer develop malignant airway obstructions as their disease progresses. Palliative care often takes place through increasing airflow in the trachea or tracheobronchial tree through dilation of the lumen. Once patients have their airflow restored, they can receive routine airway stents in the passageway.
Peytant says the benefits of AMStent include reduced migration, reduced local inflammation and granuloma formation and reduced mucus accumulation and occlusion. Dr. Craig Walker, founder, president and medical director of the Cardiovascular Institute of the South in Houma, Louisiana, called the system “a unique option for patients who need it most.”
“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 co-founder 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.”