Urocross Expander System (Model Numbers ES2018 and ES3025)

The Urocross Expander System is a temporary nitinol implant placed in the prostatic urethra to treat lower urinary tract symptoms caused by benign prostatic hyperplasia in men aged 45 and older. It mechanically expands to widen the urethral opening and improve urine flow, and is designed to remain in place for up to 6 months before retrieval.

The subject device uses a nitinol tissue expander delivered via a flexible catheter system (made of biocompatible materials including Pebax, stainless steel, polycarbonate, PTFE, PEEK, and nylon), with a push-mechanism deployment. The predicate iTind uses a similar nitinol design but with a guidewire-based deployment system and an anchoring leaflet. Both are single-use, EtO-sterilized, nitinol implants; the main differences are the delivery mechanism and indwell duration (6 months vs. 5–7 days).

ISO 10555-1, ISO 20696, ISO 10993-5/6/10/11/17/18, ISO 13485, ASTM F2129-19a and F2129-24 (corrosion), ASTM F2182-11a, F2052-15, F2213-17, F2219-13 (MR compatibility), ASTM F1980-16, F1886/F1886M-16, F2096-11, F88/F88M-15 (shelf-life), ISO 11135:2014 (sterilization validation).

Both devices are temporary nitinol implants that relieve LUTS from BPH via mechanical expansion of the prostatic urethra, use biocompatible materials, are single-use and EtO-sterilized, and share similar mechanisms of action and delivery through cystoscopy. Non-clinical testing (mechanical, biocompatibility, sterilization, shelf-life) and clinical trial data (Expander-2 IDE study showing symptom improvement and acceptable safety profile) demonstrate that the Urocross is as safe and effective as the predicate iTind System, with differences in deployment mechanism and indwell duration that do not alter suitability for intended use.