FDA approves stent for gastric diseases

The FDA has approved Cook Medical’s Evolution Duodenal Controlled-Release Stent for patients with malignant gastric outlet obstruction (GOO).

The stent is the only duodenal stent delivery system that allows for controlled release and recapturability, expanding palliative care options for patients experiencing issues with malignant GOO and extending the company’s product portfolio for the treatment of gastric diseases.

Barry Slowey, Global Business Unit Leader for Cook Medical’s Endoscopy division, said that the product “provides physicians with highly accurate stent placement, reducing the risk of migration, perforation and minimizing the need for repeat procedures”.

The Evolution’s design using 18 crowns at both ends of the stent allows the product to adapt to the anatomy’s shape. The proximal and distal flanges are designed to reduce the risk of stent migration, while the product’s Flexor catheter provides trackability and manoeuverability for deployment in the hard-to-reach duodenum.

Dr Willis Parsons, Medical Director of the Northwest Community Hospital Gastroenterology Center, said: “The stent platform is designed for optimal trackability and manoeuverability in difficult angulations, providing superior stability at crucial points during delivery.”

The stent was used in a multicentre study of 23 European patients, of which 21 patients had significant improvement of symptoms.

Mr Slowey added: “This stent has been used to treat thousands of patients around the globe, potentially improving quality of life for these patients, and hopefully minimizing the painful symptoms associated with this disease.”