Boston Scientific revealed promising 4-year-data from a post-market clinical trial evaluating the Rezūm Water Vapor Therapy in the treatment of benign prostatic hyperplasia (BPH). Results from the Marlborough, MA-based company’s trial show the device provides sexual function four years after the treatment.
The clinical trial results showed a surgical retreatment rate of 4.4% 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.
The results were published in the journal Urology and found that patients continued to experience significant and sustained improvement in their symptoms and quality of life over a 4-year-period.
"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," Dave Pierce, executive vice president and president, MedSurg, Boston Scientific, said in a release. "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."
Treatment with the Rezūm system is typically performed in a physician's office without general anesthesia and uses water vapor to remove excess prostate tissue thereby alleviating obstruction to flow, which helps reduce BPH-related symptoms.The device received FDA clearance back in 2015 and has CE mark. Boston Scientific obtained Rezūm when it acquired NxThera for about $406 million in 2018. During the 37th annual J.P. Morgan Healthcare Conference, held earlier this month, Mike Mahoney, Boston Scientific’s president and CEO, said that NxThera would help drive revenue in 2019.
“If you look at BPH we are best company to serve a continuum for a patient who has BPH disorders with the less invasive product called Rezūm,” Mahoney said according to a transcript from Seeking Alpha. “We believe [Rezūm] offers unique durability over its competition."