Introduction To Prostiva Rf Therapy; Indications; Warnings - Medtronic ProstivaRF Therapy 8930 Bedienungsanleitung

8930EN_1.fm 12/17/10 2:43 pm
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7 x 9 inches (178 mm x 229 mm)
Chapter 1
12

Introduction to Prostiva RF Therapy

Introduction to Prostiva RF Therapy

Indications

Warnings

English 8930 System User Guide 2010-12
MA07445A008 Rev X
The Medtronic Prostiva RF Therapy is a minimally invasive
treatment for patients with lower urinary tract symptoms due to
benign prostatic hyperplasia (BPH). The Medtronic Prostiva RF
System uses precisely focused radio frequency energy to ablate
prostate tissue, which helps to reduce the constriction of the
urethra and relieve BPH voiding symptoms.
The Medtronic Prostiva RF Therapy is clinically equivalent to the
Medtronic TUNA (Transurethral Needle Ablation) Therapy. The
Medtronic Prostiva RF Therapy and System represent a new
version of the radio frequency generator and hand piece that are
used for the same transurethral needle ablation procedure for
treating benign prostatic hyperplasia.
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
Refer to Chapter 5, "TUNA Therapy Clinical Overview" on
page 83 for a complete list of the contraindications, warnings,
precautions, and clinical study information.
Read all warnings, precautions, and instructions for use carefully
prior to use.
Warning: Do not use the Medtronic 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.
Medtronic Confidential
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