FDA approval for stentfix OTSC® System Set

Ovesco Endoscopy is pleased to announce that the stentfix OTSC® System Set has received market approval by the FDA. It is the innovative solution for stent fixation in the digestive tract.

The OTSC System has already been used successfully in the fixation of self-expandable metallic stents (SEMS)^1,2. However, it is not designed for proper positioning on the stent edge. The specially for the fixation of SEMS designed stentfix OTSC System now complements the OTSC System family with a further product and is the innovative solution for preventing stent migration.

The round design of the stentfix OTSC clip adapts perfectly to the gastrointestinal anatomy and the applicator cap, due to the modified shape, can easily be aligned to the stent opening for optimal stent mesh and tissue capture by the clip. Furthermore, the compact design of the stentfix OTSC System also allows the passage through a stent (from Ø 18 mm), therefore, fixation is possible either on the proximal or distal end.

More information on the stentfix OTSC® System

¹ Preventing migration of fully covered esophageal stents with an over-the-scope clip device (with videos)
Irani S., Baron TH, Gluck M, Gan I, Ross AS, Kozarek RA
Gastrointestinal Endoscopy 0016-5107

² Anchoring of self-expanding metal stents using the over-the-scope clip, and a technique for subsequent removal
Mudumbi S., Velazquez-Aviña J, Neumann H, Kyanam Kabir Baig KR, Mönkemüller K
Endoscopy 2014 Sep 30