Pilot Study of a Novel Lumen-Apposing Metal Stent (LAMS) for Endoscopic Ultrasound-Guided Procedures in Porcine Models

Aims Lumen apposing metal stents (LAMSs) have expanded the therapeutic potential of interventional endoscopic ultrasound (EUS). The Hot-Spaxus (Taewoong Medical Co, Ltd in Goyang-si, Korea), the second most commonly utilized LAMS, requires two operators for its release and this has been considered a limitation compared to other LAMS. We aimed to test the feasibility and the technical success of a newly available version of the Hot-Spaxus stent equipped with an innovative handle delivery system for EUS-guided interventional procedures [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17].

Methods We conducted a pilot study in a porcine model.The novel Hot-Spaxus 2 was tested in four EUS gallbladder drainage (EUS-GBD) and twelve EUS gastrojejunostomy (EUS-GJ) procedures using porcine models.

Results Technical success was reported in 100% of cases. The mean procedure time for EUS-GJ and EUS-GBD was respectively 23.85 minutes (SD:3.41 minutes) and 16.15 minutes (SD:2.72 minutes). The distal and proximal flanges were safely released by the endosonographer without any complications. No adverse events were reported.

Conclusions The novel Hot-Spaxus 2 stent may represent an improvement compared to the prior Spaxus model. Unlike its predecessor, this newly designed stent eliminates the need for two endoscopists and can be deployed by a single operator. Further human studies are necessary to validate its clinical effectiveness.

Publication History

Article published online:
27 March 2025

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