Niti-S SPAXUS Stent

The Niti-S SPAXUS Stent is a fully covered, self-expanding metallic stent made from nitinol with a silicone coating, designed for endoscopic drainage of pancreatic pseudocysts, walled-off necrosis, and gallbladder collections. The stent features a bi-flange design for stable positioning, radiopaque markers for fluoroscopic visualization, and is delivered via a non-electrocautery disposable delivery system. It is intended for implantation up to 60 days and should be removed upon confirmation of resolution.

The Niti-S SPAXUS uses a standard delivery system requiring auxiliary tools (versus the AXIOS predicate which offers both standard and electrocautery-enhanced delivery). Both devices employ nitinol with silicone coating, are MR Conditional, use ethylene oxide sterilization, and are provided sterile for single-patient use. The SPAXUS offers stent sizes of 8mm × 20mm, 10mm × 20mm, and 16mm × 20mm (total length), compared to the AXIOS's various saddle-length configurations (6mm × 8mm to 20mm × 10mm).

Not stated in this summary. The document references ISO 13485 (Design controls, Nonconforming product, Corrective and preventative action) in compliance sections but does not cite specific consensus standards for device testing.

Substantial equivalence is based on identical intended use (pancreatic and gallbladder drainage) and nearly identical technological characteristics—both use nitinol with silicone coating, MR Conditional design, and ethylene oxide sterilization. Biocompatibility and delivery system materials are identical to previously cleared devices (Niti-S Biliary Stent K240522 and Esophageal TTS Stent K240522). Clinical data from a 35-patient prospective study showed 97.1% success with no device-related serious adverse events, supported by three meta-analyses demonstrating comparable or superior safety and efficacy to the AXIOS predicate.