Boston Scientific (NYSE:BSX) last Friday released results from a clinical trial of its Rezūm benign prostatic hyperplasia device, touting durable results and the preservation of sexual function at four years post-treatment.
Results from the trial are set to be published in the journal Urology, and have already been published online, the Marlborough, Mass.-based company said.
“This four-year study supports the use of the first-of-its-kind Rezūm System as a minimally invasive alternative for men with moderate-to-severe BPH who do not want to rely on pharmaceutical management of their symptoms. The data demonstrate that this advanced technology can empower urologists to achieve significant clinical improvements and deliver an impactful, durable response for their patients,” lead author and co-principal investigator Dr. Kevin McVary said in a prepared statement.
The Rezūm system uses steam to treat enlarged prostate tissue that causes BPH symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Boston Scientific acquired the Rezūm system when it picked up NxThera in a $400 million deal that closed last April
Data from the trial indicates that patients treated with the Rezūm system experienced significant and sustained improvement in symptoms and quality of life over four years, Boston Scientific said. Results indicated a 4.4% surgical retreatment rate for Rezūm patients with no new adverse events reported between the third and fourth year.
Boston Scientific said that data also indicated continued preservation of sexual function that included no de novo erectile dysfunction reported at four years.
“With this study, we continue to build a strong body of clinical evidence supporting the Rezūm system as the preferred minimally invasive treatment for BPH, providing long-lasting symptom relief, while preserving sexual function. More than 35,000 patients have already been successfully treated with the Rezūm System and we have recently worked with major insurance providers to extend coverage of the procedure, providing even more men with access to this transformative technology,” Boston Scientific medsurg prez & exec VP Dave Pierce said in a press release.