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FDA Clears Liquid-Cooled Fiber for Benign Prostatic Hyperplasia

 

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The US Food and Drug Administration (FDA) has granted 510(k) clearance for a liquid-cooled fiber (MoXy; American Medical Systems) to be used with the company's recently launched 180-watt laser system (GreenLight Xcelerated Performance) for the treatment of benign prostatic hyperplasia.

The fiber features proprietary technology (Active Cooling Cap) that uses a 360° saline flow to maintain temperature at the tip, significantly increasing its longevity. The laser/fiber combination delivers 50% more power and provides a 50% increase in laser beam area compared with the previously approved 120-watt GreenLight High Performance system, effectively cutting treatment time in half.

"GreenLight laser technology has significantly improved since the global introduction of the original 80-watt PV system in 2002," noted Reza Malek, MD, in a company news release. "The 180-watt XPS system with the revolutionary MoXy fiber allows us to treat [benign prostatic hyperplasia] faster and more safely than ever before."

Dr. Malek invented the procedure commonly known as photoselective vaporization of the prostate, using a prototype 60-watt system, at the Mayo Clinic, Rochester, Minnesota, in 1997.