NxThera has announced that its Rezūm System has been used to safely and effectively treat over 10,000 patients with benign prostate hyperplasia (BPH) by more than 500 physicians in the United States and Europe.
The Rezūm System is a next-generation, hand-held transurethral needle ablation system that uses radiofrequency to create thermal energy that delivers targeted thermo-therapy — as water vapor (vapor ablation) — to remove obstructive prostate tissue in an outpatient procedure.
After treatment, the tissue is reabsorbed by the body. The company reports that improvement in lower urinary tract symptoms of BPH, like weak urinary flow or feelings of urgency to urinate, are evident in about two weeks, and that, as a noninvasive treatment, Rezūm preserves sexual and urinary functions.
“Our mission is to transform the BPH treatment experience for urologists and their patients,” Bob Paulson, president and chief executive officer of NxThera, said in a press release. “[T]he Rezūm System offers a versatile, durable and cost-effective alternative for men who are unhappy on or who discontinued their BPH medications, or who are choosing ‘watchful waiting’ rather than undergo a surgical procedure to treat their BPH. We are honored that more than 500 urologists in the U.S., together with their urologist colleagues in Germany, Sweden and England, have used the Rezūm System to treat more than 10,000 men … suffering from the debilitating lower urinary tract symptoms of BPH and significantly improve their patients’ quality of life.”
Urology experts are set to present five abstracts reporting clinical data on the Rezūm System at the upcoming 2017 American Urological Association (AUA) annual meeting in Boston, taking place on May 13 to 15, the company also announced.
The presentations will include the two-year outcomes from NxThera’s randomized, controlled, clinical study (NCT01912339) of the Rezūm System to relieve lower urinary tract symptoms (LUTS) caused by BPH.
The two-year data was published in the Journal of Urology under the title “Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia”
“Based on the conservation of sexual function and efficacy in treating LUTS/BPH, Rezūm could be offered as first-line treatment in lieu of drugs for patients with moderate to severe LUTS,” said Kevin McVary, professor and chair at the division of urology of the Southern Illinois University School of Medicine.
Nikhil Gupta, also with Southern Illinois University, will present clinical data demonstrating the effectiveness of the Rezūm System in treating obese BPH patients, in treating men with retention problems as a result of BPH, and compare the system’s effectiveness to outcomes data from the National Institute of Health’s (NIH) “Medical Therapy of Prostatic Symptoms (MTOPS)” (NCT00021814) study.
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