Prodeon Medical, a medical device company developing a minimally invasive treatment for lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH), today announced the successful completion of patient enrollment in its Expander-2 Pivotal Trial. This multi-center, randomized, blinded, controlled study is designed to evaluate the safety and efficacy of the company’s novel Urocross Expander System and the Urocross Retrieval Sheath, a minimally invasive, non-permanent implant-based treatment for patients with Lower Urinary Tract Symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

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50% of men over the age of 50 and up to 80% of all men overall, will eventually develop BPH with LUTS, representing about 40 million men in the United States who suffer from BPH (1,2,3). “We are excited to reach this important milestone in the Expander-2 Pivotal Trial,” said Paul Edwards, President and CEO of Prodeon Medical. “Completing enrollment is a key step in our mission to advance innovative treatments for BPH that improve patient outcomes and quality of life. We are thankful to our patients, investigators, and research teams for their participation and dedication to our study.”

“The removable design of the Urocross Expander as a non-permanent prostatic implant creates a new paradigm for the treatment of men with BPH who want to avoid tissue resection and sexual dysfunction.” – Dr. Dan Rukstalis, Co-Principal Investigator of the Expander-2 Trial.

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Dr. Kevin McVary, Co-Principal Investigator of the Expander-2 Trial and a world-renowned Urologist at Loyola University, shared his insights on the Urocross system: “The Urocross Expander System is impressively intuitive. Its unique design facilitates a straightforward procedure with a sensible and fluent learning curve, and I can envision how this minimally invasive device could revolutionize how we recast BPH in the future. It offers a promising solution for patients looking for relief from their symptoms without undergoing more invasive procedures.”

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Dr. Dan Rukstalis, another world-renowned Urologist at Virginia Tech and Co-Principal Investigator of the Expander-2 Trial, added “The removable design of the Urocross Expander as a non-permanent prostatic implant creates a new paradigm for the treatment of men with BPH who want to avoid tissue resection and sexual dysfunction. The fact that this system works without cutting, burning, ablating, or leaving a permanent foreign body inside the prostate is truly revolutionary. It opens up a whole new world of possibilities for how we approach treatment, offering patients effective relief with minimal intervention.”

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The Expander-2 Pivotal Trial is being conducted at leading medical institutions across the USA and Canada. Data from this trial will be used to support regulatory submissions and further the clinical understanding of this novel approach to BPH treatment.

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Source – prweb