Esophageal Stent from Cook Approved
Cook Medical received marketing clearance from the Food and Drug Administration for their Evolution Controlled Release Esophageal Stent System. The Evolution already received the CE mark required for European sales. The company detailed the device uses in a news release.
The Evolution is the only approved product delivery system that offers high levels of precision in device deployment and recapture. Precision during initial placement significantly reduces the need for multiple placement attempts. The current standard method for placement of stents within the esophagus entails a push-pull deployment system.
The placement system monitors delivery throughout placement of the stent, including a “point-of-no-return” monitor. This improves the precision available to clinicians. The stent is placed with a trigger inducer and is either released or recaptured. A simple directional button is depressed to switch between those modes.
The stent is secured with dual flanges. That feature minimizes the likelihood that the stent will become displaced. The device is coated, both internally and externally, with silicone. That material was incorporated to minimize the likelihood of tumor ingrowth. It also increases a patient’s ability to eat food naturally, rather than requiring placement of a feeding tube.
The new stent is indicated for use in patients with esophageal cancer. It is intended to provide those patients with improved overall life quality.
June 10, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Diagnostic, Gastroenterology