Prolieve Thermodilatation^® System

Prescriptive Information

• The Prolieve System is a transurethral microwave therapy device that provides a non-surgical, minimally invasive procedure for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with a prostate size of 20 to 80 grams, a prostatic urethra length between 1.2 cm and 5.5 cm and in whom drug therapy (e.g., Proscar® [Finasteride]) is typically indicated.

  Contraindications

  • Patients whose pain response has been signifcantly decreased by any means (previous surgery, regional or local anesthetic, or other relevant condition which is determined by the physician upon evaluation) because the patients' ability to detect pain is a treatment safety mechanism.
  • Severe urethral stricture preventing catheterization.
  • Current urinary or prostatic infection.
  • Presence of a penile or urinary sphincter implant.
  • Prostate size <20g or >80g.
  • Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
  • Protruding median lobe resulting in a "ball-valve" type of obstruction at the bladder neck.
  • Evidence of prostatic cancer or bladder cancer.
  • Presence of metallic implants, e.g., pelvic, femur, penile prosthesis, etc.
  • Presence of implanted cardiac pacemakers, or defibrillators.
  • Previous transurethral prostatectomy.
  • Patients interested in the preservation of future fertility.
  • Patients with a previous history of pelvic radiation.
  • Patients with coagulation disorders.
  • Patients with renal impairment.
  • Patients with neurologicial disorders that might affect bladder function.
  • Patients with bladder stones and large post voiding residual (greater than 250 mL).

  Warnings

  Patient Safety

  • The physician must monitor patient condition during the treatment. Patient comments regarding pain or excess heat in regions not associated with the expected treatment location should be fully investigated. Failure to monitor adequately and deliver the procedure per recommendations of the labeling may lead to serious patient injury.
  • There are unlikely but serious thermal (heat-related) injuries that may occur which include fistula formation and tissue damage to the penis or urethra requiring urostomies, partial amputation of the penis, and/or other therapeutic interventions, and narrowing of the penile urinary tube at any time after the treatment.
  • The physician must ensure the careful and correct placement of the catheter and temperature monitor as shown in the User Manual before heating commences. The recommended procedures for catheter and temperature monitor placement will minimize the probability of excessive temperature in normal tissue and non-therapeutic temperature in the treated area.
  • The physician must adhere to the recommended applicator placement and sterile field preparation to reduce the likelihood of surface burns and blistering from the subsequent delivery of therapeutic heat.
  • The emission of microwave energy must be off during placement and removal of the catheter to avoid stray microwave radiation directed towards the eyes (or testes) of the patient or the operator.
  • A single high dose of microwave radiation to the testes, or testicular heating for a prolonged period, may result in temporary or permanent sterility. Elevated temperatures may be expected to affect the pharmacological activity of some drugs, with unpredictable results. Altered vascular perfusion may dramatically affect the local tissue effects of systemic or infused drugs.

  Potential Adverse Effects

  • Microwave heating devices and dilatation have the potential for producing adverse events as a result of the delivery of therapeutic heat, or of the exposure to electromagnetic radiation. Those adverse events not seen in the clinical trials include: urethral stricture, pelvic abscess, allergic reaction including anaphylaxis, bladder neck contracture, urethral tear, rectal wall injury, infertility, and fistula.

Cautions

Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.

Treatment-Related Precautions

• The safety and effectiveness of the Prolieve^® System for men <50 and >80 years old has not been established in clinical studies.
• The use of the Prolieve System must be prescribed and administered under the direct supervision of a qualified and trained physician following appropriate urological evaluation of the patient.
• No anesthetic other than aqueous-based topical intraurethral anesthetic used for catheter placement is recommended.
• The user must comply with strict adherence to aseptic techniques during the placement of applicators to avoid localized infections. If the Procedure Kit seal or internal sterile packaging seals are damaged or broken, the contents may not be sterile and could cause infection. Damaged or broken seal devices should be discarded or returned.
• Treatment with the Prolieve System applies compression and deposits microwave energy, which converts to heat within the patient's prostate and in the immediately adjacent tissue. Some animal studies in the literature suggest there may be unknown health effects from exposure to microwave radiation, including an increased incidence of tumors. Althought it is not possible to extrapolate these studies to humans, they suggest that unnecessary microwave radiation exposure should be avoided.

Device-Related Precautions

• Failure to use all the components of the Prolieve System with temperature sensors in accordance with the User Manual may result in insufficient therapy and/or increased risk of injury or infection to the patient.
• Any nearby equipment operating on a similar frequency to that of the Prolieve System should be operated at a distance of at least 2 meters (6.5 ft.) (including locations behind adjacent walls) to avoid device-to-device interference. Such devices include but are not limited to cell phones and/or other sensitive treatment and monitoring equipment (e.g., drug infusion devices, physiological devices.)
• The Prolieve System is designed to operate in a room with adequate space for the patient, treatment bed, permanent instrument, with adequate lighting, and clinical personnel. The treatment room should also be clean and support the needs of the physician to treat in a sterile field. Failure to provide these may have a deleterious effect on the patient and/or treatment result.
• Any modifications made to equipment or software without explicit approval from the manufacturer poses a potential safety threat to the operators and patients. Only qualified, trained personnel should be allowed to operate the equipment. Please consult the User Manual for specific technical warnings and precautions on device operation.

Operator-Related Precautions

• Equipment covers must never be removed with primary power connected to the equipment due to a risk of electrical shock.

Trademark

Proscar is a trademark of Merck & Co.