Indications, Safety, and Warnings

Indications

The Targis® System is a non-surgical device intended to be used as an in-office BPH treatment to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH).

Read all warnings, precautions, and instructions for use carefully prior to use.

Warnings

• Only those physicians who have been thoroughly trained on the operation of the Targis System and the Cooled ThermoTherapy procedure should deliver the Cooled ThermoTherapy procedure.
• The Targis System and components should not be used in any way other than the intended and indicated use and according to the Instructions for Use.
• This outpatient enlarged prostate treatment procedure must not be initiated without assurance that the Microwave Catheter is properly positioned in the patient.
• The Cooled ThermoTherapy procedure must not be initiated until an enema has been given and the RTU is properly placed into the patient’s rectum and inflated.
•  It is important that the patient not be over sedated. This may compromise his ability to communicate pain.
• All components of the Targis System must be used in a manner consistent with the instructions set forth in their respective Instructions for Use insert and the Targis System User Manual. Failure to do so may result in insufficient treatment or increased risk of injury or infection to the patient.

Contraindications

Patients with the following conditions should not be treated:

• Patients with a prostatic urethra<2.5 cm in length, measured from the bladder neck to the verumontanum.
• Patients with urinary sphincter or any implant (metallic or non-metallic) which is within 1.5 inches (38 mm) of the prostatic urethra.
• Patients with urethral stricture (unable to pass 22 F urethroscope).
• Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e. claudication of the buttocks or perineum).
• Patients who have undergone pelvic radiation therapy.
• Patients with implanted active devices, including pacemakers or defibrillators, within 2.6 inches (6.5 cm) of the prostatic urethra.
• For patients with active implanted devices located greater than 2.6 inches (6.5 cm) from the prostatic urethra, it is recommended that non-cardiac devices be turned OFF during treatment with the Targis System, if possible(e.g. active implanted devices used in the treatment of pain or incontinence), to lessen the likelihood of adverse interaction caused by electromagnetic interference.

Potential Adverse Effects

The following complications have been observed:

Post-treatment catheterization, mild hematuria, dysuria, clots in urine, temporary or partial ejaculate loss, pain or irritation in the groin or pelvis, bladder spasms, hemospermia, prostatic urethra damage, rectal irritation, temporary acute incontinence, interrupted flow, sensation of not emptying bladder, bladder trabeculation, severe pain during treatment, pain or discomfort during sexual activity, frequency, hesitancy, urgency, post-void dribbling, blood pressure changes during treatment, hospitalization in general related to treatment, transient erectile dysfunction, urinary tract infection, complete loss of ejaculate, bladder diverticali, weak stream, erectile dysfunction, epididymitis, prostatitis, nocturia, urethral stricture, and rectal fistula.

Caution: Federal (U.S.A.) law restricts this device by or on the order of a physician trained and/or experienced in the use of this device. For more complete information about the benefits, risks and contraindications associated with this procedure, please refer to the Instructions for Use and Users Manual. Indications, contraindications, warnings and instructions for use can be found with the product labeling packaged with this device.

For Instructions for Use please click here to Download the User Manual.