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Fact Sheet

PROSTIVA™ RF Therapy Fact Sheet

Medtronic PROSTIVA™ RF Therapy
for Enlarged Prostate

Overview
PROSTIVA RF (radio frequency) Therapy is a minimally-invasive treatment for symptomatic benign prostatic hyperplasia (BPH). The PROSTIVA RF Therapy System delivers low-level radio frequency energy directly into the prostate and destroys the prostate tissue, improving the symptoms of BPH.

Indication
PROSTIVA RF Therapy is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men over the age of 50 with prostate sizes between 20 cc and 50 cc.

Benefits

• Provides long-term relief of BPH symptoms from one treatment session
• Associated with few side effects and adverse events.¹
• Takes less than one hour on average
• Can be performed under local anesthesia
• Treatment is targeted; adjacent tissues and organs are preserved.
• Cost effective: Can be performed as an outpatient procedure in a urologist’s office
• Affordable: Covered by Medicare and most private health plans

PROSTIVA RF Therapy System

• The major components of the PROSTIVA System are the radio frequency (RF) generator, the disposable handpiece and the telescope.
• The generator is a portable, line-powered, dual channel generator, capable of producing up to 15 watts per channel. The generator produces RF energy at 473 kHz.  This is the same approximate frequency as cautery and other RF ablation devices.
• The handpiece, including the RF cable, comes as a complete sterile assembly that contains two insulated needles. The entire assembly is a single use, disposable device.
• The telescope allows the physician to view anatomical landmarks and the needle deployment sites directly.

Procedure and Follow-up

• PROSTIVA RF Therapy total procedure time is less than one hour, with some preparation and recovery time required. The PROSTIVA generator lesion time is 22 percent faster than the previous generation of RF therapy.
• PROSTIVA RF Therapy treats the median and lateral lobe as well as asymmetrical prostates. (Exception: Median lobes that protrude into the bladder and collapse over the bladder neck.)
• The device is inserted into the urethra and deploys two custom-set needle electrodes into the obstructing prostate tissue. The needles emit radio frequency (RF) energy directly and precisely into the prostate, causing thermal ablation of the obstructing tissue.
• Most patients can undergo the PROSTIVA procedure with only a sedative and a local anesthetic.
• Forty percent of patients were catheterized in the original clinical study. In later studies, 6–15 percent of patients were catheterized.²
• Most patients are able to return to normal activities within a few days.

Safety Profile

• Clinical trials demonstrated that the RF therapy procedure can be performed without the need for general or regional (spinal) anesthesia; most patients require only mild sedation, topical anesthesia, and/or a prostate block.
• RF therapy is associated with few side effects and adverse events, which may include obstruction, catheterization, bleeding, pain/discomfort, urgency, frequency and urinary tract infection.³

History

• Previously, the only BPH treatment options were daily drug therapy or surgery.
• With the development of minimally invasive therapies, patients now have a selection of BPH treatment choices to better meet their lifestyle and health needs.
• RF energy has been used in medical procedures since the 1920s. In cardiac and neurosurgery treatments, RF has been recognized as a safe and effective treatment for many medical conditions.
• Initial pilot studies of the first generation of RF therapy for the prostate began in 1994, followed by a series of clinical trials to determine safety, efficacy and durability. When comparing side effects and adverse events, RF therapy compared favorably to TURP in a major U.S. clinical trial.⁴
• TUNA Therapy, the previous generation of PROSTIVA RF Therapy, was introduced in the United States in 1996 for the treatment of the symptoms of BPH.
• In November 2005, the Food and Drug Administration granted 510K clearance to PROSTIVA RF Therapy as equivalent to TUNA® Therapy. ⁵
• Medtronic released the PROSTIVA RF Therapy System to the market in Spring 2006.

Cost and Coverage

• The current initial set-up cost of the PROSTIVA RF Therapy system (generator and scope) is approximately US $15,000.
• Studies show that TUNA Therapy, the previous generation of PROSTIVA,  is 40 to 70 percent less expensive than TURP.⁶
• The cost of PROSTIVA RF Therapy to patients varies by benefit plan.
• Cost savings are also realized with the limited recovery time and decreased morbidity of PROSTIVA RF Therapy as compared to TURP.
• PROSTIVA RF Therapy is covered by Medicare in all 50 states, as well as by many private pay and managed care insurance companies. Most patients will be responsible for a deductible and/or co-payment/co-insurance.
• Medicare reimburses physicians for performing the PROSTIVA procedure in their offices.

References

¹ Medtronic PROSTIVA RF Therapy System User Guide
² Ibid
³ Ibid
⁴ Ibid
⁵ Data on file at Medtronic, Inc.
⁶ Issa MM, Marshall FF. Contemporary Diagnosis and Management of Diseases of the Prostate. Newtown, Pa: Handbooks in Healthcare Co.; 2005.