Rezum Radiofrequency System receives 510(k) approval from the FDA for benign prostatic hyperplasia-NxThera

NxThera, which is pioneering the application of its Convective Water Vapor Energy (WAVE) platform technology to treat endourological conditions, has announced it has received FDA 510(k) clearance of the company's Rezum System to treat Benign Prostatic Hyperplasia (BPH). Approval is based on clinical data from the Rezum II randomized, controlled clinical study which demonstrated clinically and statistically significant BPH symptom improvement in as little as two weeks, as well as meaningful improvements in the quality of life for patients.

Comment: NxThera has pioneered its Convective Water Vapor Energy (WAVE) technology platform to treat a variety of endourological conditions beginning with BPH, and including prostate cancer and kidney cancer. NxThera's Rezum System to treat BPH uses radiofrequency energy to create sterile water vapor, or steam, to convectively deliver targeted, precise thermal energy treatments in a simple, office-based or hospital procedure with minimal discomfort, and provide improvements in urine flow and quality of life.