PROSTIVA RF THERAPY BRIEF DISCLOSURE

Indications: The PROSTIVA™ RF Therapy System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.

Adverse Events: Side effects may include obstruction, catheterization, bleeding, pain/discomfort, urgency, frequency, and urinary tract infection.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions and warnings, please refer to the System User Guide.

For additional information about PROSTIVA RF Therapy, please see the complete PROSTIVA RF Therapy Safety Data.