Loyola University Medical Center

Prodeon Medical's Urocross Expander System Receives FDA Clearance for Non-Permanent BPH Treatment

- The FDA has cleared Prodeon Medical's Urocross Expander System, a novel non-permanent implant for treating lower urinary tract symptoms associated with benign prostatic hyperplasia. - Clinical trial data from 240 patients showed 48.1% mean improvement in symptom scores at 12 months, with 74.5% of patients achieving clinically meaningful symptom relief. - The retrievable nitinol-based implant remodels prostatic tissue over six months before removal, preserving sexual function and future treatment options. - The technology represents a new category of BPH intervention that avoids permanent implants or irreversible tissue damage, addressing an estimated 40 million affected men in the US.