Indications, Safety, and Warnings
The Prostiva® RF 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 cm.
Read all warnings, precautions, and instructions for use carefully prior to use.
- Do not use the Prostiva® RF System without reading all warnings, precautions, and instructions for use carefully prior to use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.
- The Prostiva® RF therapy introduces needle perforations into organs or structures within the therapeutic prostate region which may result in fistulas within those organs or surrounding structures and could lead to serious health events for the patient.
Patients with the following conditions should not be treated:
- Patients with an active urinary tract infection
- Neurogenic, decompensated or atonic bladder (patients with suspect bladder function should undergo a urodynamic evaluation to rule out atonic, decompensated, or neurogenic bladder syndrome)
- Urethral strictures or muscle spasms that prevent insertion of the hand piece sheath
- Bleeding disorders or patients taking anticoagulation medication unless antiplatelet medication has been discontinued for at least 10 days
- ASA class group V patients
- Clinical or histological evidence of prostatic cancer or bladder cancer
- A prostate gland which is less than 34 mm or greater than 80 mm in transverse diameter
- Presence of any prosthetic device in the region that may interfere with the procedure
- Patients whose prostate has been previously treated with non-pharmacological therapies (such as TUMT, Laser, or TURP)
- Presence of a cardiac pacemaker, implantable defibrillator, or malleable penile implants
- Patients with any component(s) of an implantable neurostimulation system; energy from the Prostiva® RF System may be transferred through the implanted system and may damage the patient’s tissue in the area of the implanted system components. This applies whether the neurostimulation system is “off” or “on”. The neurostimulation system components may also be damaged.
For Instructions for Use please click here to Download the User Manual.