Taking care of terminal patients with an advanced esophageal cancer is a difficult task, both from a clinical perspective and a psychological one. This new minimally invasive device from Cook Medical, called Evolution® Controlled Release Esophageal Stent System, recently granted 510(k) clearance from the FDA, should make care more compassionate, while improving the quality of life of patients.
The Evolution stent’s retractable delivery system facilitates direct monitoring of the placement progress throughout the procedure with it’s “point-of-no-return” indicator, allowing physicians more controlled placement of the stent. With each squeeze of the stent’s trigger-based introducer, a proportional length of the stent is deployed or recaptured. The directional button enables seamless switching from deployment to recapture mode and the “point-of-no-return” mark alerts the physician when recapture is no longer available. However, even after this point repositioning is still an option.
The Evolution Stent is designed with dual flanges that secure the stent, potentially reducing the risk of migration or stent movement after placement, thus eliminating the need for repeat procedures. It is also the only esophageal stent with an internal and external silicone coating, designed to resist tumor ingrowth into the stent and enhances the patients’ ability to swallow food normally instead of eating through a tube.
Press release: Cook Medical Announces FDA 510(k) Clearance of Evolution® Controlled Release Esophageal Stent System