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FDA grants 510(k) approval for NxThera’s Rezum System to treat BPH

Medical device firm NxThera has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Rezūm System to treat benign prostate hyperplasia (BPH).

The system is said to use radiofrequency energy to translate sterile water into stored thermal energy in the form of vapor or steam.

This water vapor will be convectively delivered directly into the obstructive prostate tissue, which causes BPH.

In the tissue, condensation releases adequate thermal energy to gently and immediately denature the targeted prostate tissue cells to cause necrosis. The treated tissue will be ingested by the natural immune system of the body.

NxThera president and CEO Robert Paulson said: "FDA clearance of our Rezum System to treat BPH is a significant milestone for NxThera and our team of dedicated and passionate employees, and a testament to the vision and commitment of our many clinical advisors, clinical study investigators, investors, and our founder and chief technology officer Michael Hoey.

"We now will shift our focus to accelerating and expanding access to and adoption of the Rezum procedure in the US during early 2016, and expanding into key international markets later in the year."

According to the firm, around 12 million American men suffer from BPH, with over 750,000 new cases diagnosed each year.