The Urocross Expander System is an investigational device developed by Prodeon Medical, Inc, to transform the approach of treating lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH).
Around 50% of men aged 50 and above experience LUTS attributable to BPH. In men over 80 years old, this rises to over 80%. Symptoms include increased frequency of urination, nocturia, hesitancy, urgency, and weak urinary stream.
Current BPH treatment methods are associated with a multitude of side effects including sexual dysfunction. Treatment with medication is commonly linked to several potential negative side effects such as dizziness, hypotension, erectile dysfunction, and incomplete symptom relief. Surgical treatment options, including the gold standard transurethral resection of the prostate (TURP) or laser surgery, can offer durable symptom relief but may lead to permanent side effects including sexual function. Other minimally invasive treatment options may require higher levels of anesthesia and significant use of pain medication, may cause permanent damage to the prostatic tissue, and in some cases, may require the temporary need for a urinary catheter after the procedure.
Prodeon Medical, Inc. has developed and is investigating a minimally invasive and patient-friendly approach to treating LUTS secondary to BPH known as the PURETM (Prostatic Urethral REshaping) procedure using the Urocross Expander System and Retrieval Sheath. The Urocross Expander is designed to widen the narrowed prostatic urethra tissue, creating an open urethral lumen for normal urinary flow. The Urocross Expander is intended to be removed after a period of six months using the Urocross Retrieval Sheath, leaving no permanent foreign body behind.
The PURE procedure is conducted by way of standard flexible cystoscopy techniques in a variety of facility settings, including Hospital Outpatient and Ambulatory Surgical Centers (ASCs).
Medeon firmly believes that the Urocross Expander System may represent a significant leap forward in the treatment of LUTS caused by BPH. Clinical studies are ongoing. The Urocross Expander System and Retrieval Sheath are for investigational use in the Expander-2 Pivotal Clinical Trial only and are not for sale in the U.S. or outside the U.S.