Rezum System

Boston Scientific announces 4-year data for Rezūm BPH treatment

Posted on January 28, 2019 by Medtech[y] Staff

Boston Scientific (NYSE: BSX) recently announced that data from a randomized clinical trial demonstrate that Rezūm Water Vapor Therapy, a minimally invasive treatment for benign prostatic hyperplasia (BPH), provides durable results and preserves sexual function four years after treatment. The study, published online ahead of print by Urology, found that patients continued to experience significant and sustained improvement in their symptoms and quality of life over this period.

Boston Scientific acquired the Rezūm System in 2018 as part of their acquisition of NxThera, expanding the company's offerings for the treatment of symptomatic BPH, including the Greenlight XPS Laser Therapy system and holmium platforms.

The Rezūm System treats the symptoms of BPH by using water vapor to kill prostate adenoma cells, leading to the cell remnants being absorbed by the body. The procedure can be performed in a physician's office without general anesthesia in a single visit and does not require implants to be placed in the body. The Rezūm System is included in The American Urological Association's BPH treatment guidelines and now has four-year follow-up data showing it can reduce the size of the prostate in all areas of enlarged prostate zones.

What is Boston Scientific's Rezūm System?

"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," said Kevin McVary, MD, FACS, lead author and co-principal investigator of the Rezūm II Trial. "The data demonstrate that this advanced technology can empower urologists to achieve significant clinical improvements and deliver an impactful, durable response for their patients."

Over the four years, the trial showed a surgical retreatment rate of 4.4 percent and no new adverse events noted between years three and four. The clinical results also highlighted continued preservation of sexual function, including 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," said Dave Pierce, executive vice president and president, MedSurg, Boston Scientific. "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."