Rezūm System Granted 510(k) Clearance

By Policy and Advocacy Brief posted 10-12-2015 13:29


On August 27, 2015, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to the Rezūm System developed by NxThera, Inc. The Rezūm System is intended to relieve symptoms, obstruction, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men ≥50 years of age with a prostate volume ≥30 cm and ≤80 cm.  The Rezūm System is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.

The Rezūm System uses radiofrequency energy to transform sterile water into stored thermal energy in the form of vapor, or steam. This water vapor is convectively delivered directly into the obstructive prostate tissue that causes BPH, where condensation releases enough thermal energy to denature the targeted prostate tissue cells to cause necrosis.  The treated tissue is absorbed by the body's natural immune system.

To report the Rezūm procedure on medical claims, use CPT code 53852 Transurethral destruction of prostate tissue; by radiofrequency thermotherapy.