Prescriptive Information
Prescriptive Information
Indications:
The Targis® System is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH).
Targis System Description:
The Targis System is comprised of a Control Unit which produces the microwave energy and monitors all aspects of the Cooled ThermoTherapy procedure, a Microwave Catheter which delivers the microwave energy to the targeted prostatic tissue, an RTU which measures rectal temperatures during the Cooled ThermoTherapy procedure and a Coolant Bag which provides a reservoir of sterile coolant water to the Microwave Catheter. The Targis System treats BPH by applying microwave power to the prostate, and continuously heating the diseased tissue via transurethral catheter. It also minimizes patient discomfort and risk to the urethra by circulating cooling fluid through the Microwave Catheter.
Contraindications:
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.
Warnings & Precautions
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. The Cooled ThermoTherapy 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.
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 to sale by or on the order of a physician.
View the complete Instructions for Use by selecting the Product Downloads tab on this page.
