About

VacStent GI^TM. targets the clinical problems of perforations and surgical leaks in the gastrointestinal tract (esophagus, stomach, intestine, colon). These represent a special clinical challenge, which is associated with high morbidity and mortality. Endoscopic procedures are able to significantly improve the treatment options but are each associated with procedural restrictions and disadvantages. The commonly used solutions are (i) fully covered stents (no vacuum) and (ii) endoscopic vacuum therapy with a polyurethane sponge (no stent). Now, in the case (i) a stent can seal the leakage, but in over 50% of the cases will move (be dislocated) by the peristaltic dynamics. Also, a stent cannot drain the wound secretions. On the other hand, the endoluminal vacuum sponge of case (ii) brings all the benefits of vacuum treatment but blocks the passage of the gastrointestinal tract, which brings new clinical problems or is flatly not applicable.

VacStentGI^TM. is a patented innovation in endoscopic therapy for leaks because it COMBINES the advantages of the covered stent with those of improving wound healing through vacuum drainage.

VacStentGI^TM. consists of a silicone-coated, self-expanding superelastic NiTi stent with a cylindrical polyurethane sponge on the outside, connected via catheter to a vacuum source. A continuous suction of -80 to -120 mm Hg is applied to the sponge. VacStent GI^TM. is as easy to apply as any GI^TM. stent. It won’t dislocate because the suction keeps it in place, even in difficult topographic locations of the GI^TM. tract. However, it allows for the open passage of endoscopic instruments, enteral nutrition, and intestinal contents.

VacStent GI^TM. has obtained the CE mark as a class 2 A medical device. Clinical applications in the esophagus have so far been carried out as part of clinical studies and accompanied implantations.