US clearance for Cook's Evolution oesophageal stent
This article was originally published in Clinica
Executive Summary
Cook Medical has received US FDA 510(k) clearance for its Evolution controlled-release oesophageal stent system for oesophageal cancer. The Bloomington, Indiana-based firm said it was "the first and only stent delivery system that enables deployment and recapturability of the stent with unprecedented precision". As the stent can be placed precisely the first time, this may reduce the need for repeat procedures. It has a retractable delivery system and a "point-of-no-return" indicator which alerts the physician when recapture is no longer available. It is also the only oesophageal stent with an internal and external silicone coating, Cook claims, which resists tumour ingrowth into the stent and enhances patients' ability to swallow food normally.
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