Author: Salvatore Docimo, Jr., DO
Ovesco received FDA Approval for the Stentfix OTSC System Set in October 2019.
The stentfix OTSC (over the scope clips) system is designed for stent fixation in the digestive system. The clip can be deployed either at the proximal or distal end of the stent. The deployment cap has been specially redesigned to allow the stentfix OTSC clip to be easily positioned parallel to the stent opening in order to grasp an optimal amount of tissue and stent for fixation. Stentfix OTSC clips also have a rounded design that allows for deployment without obstructing food passage into the distal lumen.
The stentfix OTSC system consists of the applicator cap, stentfix clip, thread, thread retriever, and a hand wheel for clip deployment. The applicator cap can be affixed to endoscopes with diameters of 8.5-10 mm and has a cap depth of 7 mm. The entire stentfix OTSC system outer diameter is 14.6 mm. The clip is made of Nitinol and considered MRI safe.
In order to place the clip in the proximal end of the stent, the endoscopist should align the clip tooth rows parallel to the stent opening so the tissue and stent are evenly captured during deployment. Deployment of a clip on the distal end of the stent often requires the use of a tissue grasper. The endoscopist aligns the clip tooth rows parallel to the stent opening and the tissue grasper mobilizes the tissue below the stent into the cap. The stentfix OTSC is then deployed, capturing both the stent and the tissue which has been pulled up into the cap by the grasper.
The FDA determined the stentfix OTSC system to be substantially equivalent to predicate devices. The indications for use include, “Instrument for flexible endoscopy for fixation of metal stents in the gastrointestinal tract for use in adults only.”1
Figure 1. Stentfix OTSC System Set
Figure 2. Dimensions of the stentfix OTSC system.2
Mini OTSC System
Ovesco received FDA Approval for the mini OTSC System Set in January of 2019.
The mini OTSC System extends the current OTSC family of clips to a smaller size. The mini can be fixated on an endoscope diameter of 8.5-9.8 mm. The maximum outer diameter of the application system is 14.6 mm; this is compared to previous OTSC systems which had ranged in outer diameter from 16.5 mm to 21 mm. The clip is made of Nitinol and can remain with the body as an implant.
It is currently indicated for use during “acute bleedings, full thickness wall closure, compression, as well as approximation of tissue and management of complications after endoscopic or surgical interventions, especially in small lumens or where access is an issue.”2
Figure 3: Dimensions of the mini OTSC System.3
- FDA U.S. Food & Drug Administration. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183309.pdf. Accessed 4/18/20
- Dimensions and specifications. https://ovesco.com/stentfix-otsc-system/#Technical-Data. Accessed 4/18/20.
- Dimensions and specifications. https://ovesco.com/mini-otsc-system-set/#Technical-Data. Accessed 4/18/20.