8930EN_5.fm 12/17/10 2:44 pm
UCxxxxxx EN
7 x 9 inches (178 mm x 229 mm)
Chapter 5
84
Overview
Overview
Indications
Contraindications
English 8930 System User Guide 2010-12
MA07445A008
Rev X
The Medtronic TUNA (Transurethral Needle Ablation) 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
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
Medtronic Confidential
CRMRef_R06
3
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