Shots:
- The US FDA has granted 510(k) clearance to the Urocross Expander System for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), backed by extensive data incl. the Expander-1 & Expander-2 trials
- Expander-2 (n=240) showed mean 48.1% IPSS improvement & a 74.5% responder rate (≥30% IPSS reduction) at 12mos. post implantation (6mos. post retrieval). Pts also observed preserved sexual function & high tolerability
- The Urocross procedure uses a flexible cystoscope to place a temporary implant that remodels obstructed prostatic tissue & is removed within 6mos., avoiding cutting or ablation & preserving future diagnostic & treatment options
Ref: Globenewswire | Image: Prodeon | Press Release
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