Post written by Andrew Storm, MD, from Mayo Clinic, Rochester, Minnesota, USA.

With the growth of novel transmural endoscopic ultrasound (EUS)—directed therapies in the gastrointestinal tract, awareness of the need for innovations to make these procedures safer and more reproducible is increasing. Such improvements are necessary to assure widespread access for patients who will benefit from wider access to these wonderful minimally invasive therapies.

One such necessary procedural improvement is a device that permits tacking or securing of 2 lumens side by side prior to deployment of a lumen-apposing metal stent as in EUS-guided cholecystoduodenostomy, gastrojejunostomy, and hepaticogastrostomy.

In our pilot study, a new device (SofTac EndoFix; Waltham, Mass, USA) was evaluated. The device uses a 10-cm-long nitinol fine-needle aspiration platform and surgical suture “tags,” which may be extruded under ultrasound guidance into a nearby lumen and then cinched to the proximal lumen. Porcine gallbladder anatomy is often very challenging for EUS-guided gallbladder access, as the porcine gallbladder is generally deeply embedded within the 5 to 6 unique liver lobes, rather than being simply along the inferior edge of the liver, as seen in human anatomy. As such, the porcine gallbladder is a great worst-case scenario for training and testing new devices for EUS-guided gallbladder access.

Our study, which includes video of both room and endoscopic footage from the procedure, concluded that the EndoFix device had a significant impact on the performance of a safe freehand EUS-guided gallbladder access procedure and may have a role in the improvement of other EUS-guided lumen-apposing procedures. This pilot study informed a larger survival study aimed at future U.S. Food and Drug Administration approval of the EndoFix device. We hope you will scope out our article in the March 2025 issue of iGIE.

Gallbladder (arrow) visualized endosonographically, notably in a location far from the gastric wall (arrowhead).

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