The FDA has granted a de novo clearance to a new type of stent designed to hold open the passages down the windpipe and into the lungs, among patients that may have their airways pinched and blocked by growing cancers.
Peytant Solutions’ minimally invasive AMStent system includes a metal frame encased in a material sourced from human amnion, the pliable membrane that helps form the amniotic sac. Processed amnion has been used in several medical specialties for years, including in the treatment of chronic wounds, burns and skin ulcers.
The Minnesota-based company said the decellularized, tissue-based covering helps to hold the stent in place, in addition to reducing the local inflammation and the accumulation of mucus that can make it difficult for the patient to breathe. The stent itself does not carry any pharmaceutical drug coating.
“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,” Peytant’s co-founder and CEO, John Schorgl, said in a statement. “With the availability of the AMStent system, we hope to improve the palliative care and thereby the quality of life for these patients.”
The company described the catheter-deployed implant as the first in a covered-stent portfolio that will also aim to tackle diseases that block the arteries and veins as well as the gastrointestinal and urinary tracts.