Cook Medical, a supplier of endoscopic devices, has received the US Food and Drug Administration (FDA) 510(k) clearance for Evolution controlled-release esophageal stent fully covered in silicone.
The Evolution fully covered stent comes with silicone internal and external of the stent that resists tumor ingrowth and makes swallowing more comfortable for the patient, Cook Medical said.
The Evolution stent is designed to improve quality of life for patients with malignant esophageal strictures and tracheoesophageal fistulas (TEF) by improving the patients’ ability to swallow, and its silicone that fully covers the stent helps prevent tumor ingrowth.
The fully covered Evolution is also designed to secure the stent in the esophageal tract, reducing the risk of stent migration after placement and eliminating the need for repeat procedures.
Cook Medical endoscopy division global business unit leader Barry Slowey said that the Evolution Fully Covered Stent offers physicians more control and less stress in stent placement and recapture.
“The addition of the fully covered stent to Cook’s existing Evolution product line provides more options to physicians to treat their esophageal cancer patients,” Slowey said.