Anatomy and Physiology

Anatomy and Physiology

Nerve Supply to Prostate

Prostate Nerve Supply Nerve supply received from neurovascular bundles
Innervated by autonomic and sensory nerves Originates from the pelvic and hypogastric fibers Nerves coalesce at tips of seminal vesicles to form the pelvic plexus

Importance of Nerve Supply
Neurovascular bundles responsible for erectile function Consideration for comfort control during PROSTIVA® RF Therapy procedure

Prostate Blood Supply Two main arteries supply the prostate
Positioned at 11 and 1 o’clock Reduced blood supply will impede growth of prostate The prostate gland is surrounded by vessels and nerves Two main arteries which supply the prostate come in at 5 and 7 o’clock position Interference of blood supply will impede abnormal cellular activities

Clinical Implications for Benign Prostatic Hyperplasia (BPH) Therapy
Stroma (fibromuscular) predominant BPH Responds to -adrenergic blockers which exert their effect on the muscle Epithelial (glandular) predominant BPH Responds to androgen suppression therapy such as 5- reductase inhibitors, which inhibits the conversion of testosterone to DHT Alpha blockers were initially tested for the treatment of high blood pressure and were soon found to relieve BPH symptoms Issa M, Contemporary Diag and Mgmt,

-Adrenergic Receptor Distribution in the Lower Urinary Tract
-1D adrenoreceptors -1A adrenoreceptors

Prostate Zones - Peripheral zone - 70% of prostate
- Central zone - 25% of prostate - Transitional zone - 5% of prostate Where BPH occurs; small percentage of total prostate Zonal classification is mainly for pathologic purposes Practical purposes for various conditions of the prostate such as BPH. BPH primarily affects the transition zone Most prostate cancer (approx 70%) is found in the peripheral zone Issa M, Marshall F. Contemporary Diagnosis and Management of Diseases of the Prostate. 3rd ed. Newtown, Pa: Handbooks in Healthcare Co; 2005.

Located anteriorly but surrounds the urethra
Transitional Zone Located anteriorly but surrounds the urethra BPH primarily affects the transitional zone Percentage of the prostate Peripheral zone - 70% Central zone - 25% Transitional zone - 5%

Benign Prostatic Hyperplasia (BPH) Overview

Symptomatic BPH Population
US Prevalence: 14.9 Million US Incidence: 500,000 Translates to: 50% of men over 50 60% of men over 60 70% of men over 70 80% of men over 80 US Census; Millennium Research, 2006; A.G. Edwards & Son, 2006.

Why Treat BPH? BPH is not cancer but it can lead to unwanted complications if not corrected Urine retention and strain on the bladder can lead to Urinary tract infections Bladder or kidney damage Bladder stones Incontinence When BPH is diagnosed and treated early, there is a lower risk of developing such complications

Quality of Life of Untreated BPH
Before PROSTIVA® RF Therapy I couldn’t play golf because if I’d get out there I had to stop and find a bathroom to go. --Harold I just had to go an awful lot – five or six times a night. --Paul I didn’t really mind so much the fact that it was difficult to start urination, but what I really did mind was having the leakage. --Bill It has an impact because first of all when you go into a strange store or a strange building, the first thing you have to zero in on is where are the restrooms. --Richard I carried a cup in the car so I could urinate. I’ve urinated to relieve myself going 60 miles an hour! --Moses After PROSTIVA RF Therapy The RF Therapy has changed my life. It has allowed me to do things that I couldn’t do without conditions before. --Richard Prior to the RF Therapy, I was on two expensive medications for prostate problems and one of them I had to take twice a day. And after the Therapy, I’ve been able to drop them and don’t have to take them anymore which is great. --Bobby PROSTIVA RF Therapy is the best thing I ever did in my life. --Harold

Click box to activate video
This video clip is one patient’s experience only and may not reflect other patients' experiences

Benign Prostatic Hyperplasia (BPH) Patient Evaluation and Diagnosis

BPH Diagnosis and Treatment Algorithm
Initial Evaluation History DRE & Focused PE Urinalysis PSA Presence of Refractory retention or any of the following clearly related to BPH Persistent gross hematuria Bladder stones Recurrent UTIs Renal insufficiency AUA/IPSS Symptom Index Assessment of Patient Bother Moderate/Severe Symptoms (AUA/IPSS 8) Mild Symptoms (AUA/IPSS 7) or No Bothersome Symptoms Surgery Optional Diagnostic Tests Uroflow PVR Discussion of Treatment Options Optional Diagnostic Tests Pressure flow Urethrocystoscopy Prostate ultrasound Patient Chooses Noninvasive Therapy Patient Chooses Invasive Therapy Watchful Waiting Medical Therapy Minimally Invasive Therapies Surgery AUA Guideline 2003/updated 2006.

Further Evaluation Warranted?
Abnormal DRE Abnormal PSA Prior therapy for LUTS/BPH Non-response to medical therapy <50 years of age History of diabetes History of pelvic surgery/ trauma Neurologic symptoms/ disease Renal insufficiency If results of the initial evaluation of the patient are not consistent with BPH or reveal other pathologies, additional diagnostic testing is warranted. Listed on this slide are the conditions/states that warrant further evaluation of those presenting with symptoms suggestive of BPH. Although BPH is extremely common in men aged 50 years or older, symptoms of prostatism occurring in men less than 50 years of age requires further assessment. The evaluation of PSA levels in patients with BPH is optional. It is also complicated by the elevations in serum PSA levels normally associated with BPH and the effects of BPH medications on PSA levels. Still, an abnormal level must be further explored for its potential in detecting a prostate cancer. LUTS associated with BPH also can be associated with other diseases. Men who have previously been treated but failed to respond require additional evaluation, either as a first step in a revised treatment approach or to identify another condition. A history of prior instrumentation, prostate surgery, trauma, or urethritis may suggest urethral stricture and should be investigated. As noted above, LUTS can occur in other conditions. The differential diagnosis for LUTS in older men includes diabetes, neurologic conditions, and congestive heart failure, among others. Patients with severe symptoms, including renal insufficiency, most likely require more extensive evaluation and subsequent surgery. Finally, treatment nonresponders require further work-up to determine the next appropriate course of action. 1. Arrighi HM, Guess HA, Metter EJ, et al. Symptoms and signs of prostatism as risk factors for prostatectomy. Prostate ;16: 2. McConnell JD, Barry MJ, Bruskewitz RC, et al. Benign Prostatic Hyperplasia: Diagnosis and Treatment. Clinical Practice Guideline, Number 8. AHCPR Publication No Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. February 1994. 3. Ziada A, Rosenblum M, Crawford ED. Benign prostatic hyperplasia: an overview. Urology. 1999;53:1-6. AUA Guideline 2003/updated 2006.

Questions to Ask Relative to History
Oral intake Timing Caffeine Alcohol Medications affecting volume Diuretics Stool-bulking agents Medications affecting voiding Antihistamines Decongestants Diseases Diabetes Congestive heart failure Neurologic The detailed medical history focuses on the general health issues and issues specific to the urinary tract. It provides the clinician a chance to ask about previous surgical procedures or fitness for a future surgical procedure. The history-taking also provides a chance to identify other causes of voiding dysfunction or comorbidities.1,2 At the time of history-taking, questions to focus on include the following: oral intake of fluids, including the types of fluid, when taken, and how much current medications confounding/concomitant diseases Diabetes is a risk factor for BPH. It also has symptoms similar to BPH and should be ruled out. Other conditions that are part of the differential diagnosis of BPH include congestive heart failure and neurologic conditions, such as stroke, multiple sclerosis, and Parkinson’s disease. References AUA Guideline 2003 McConnell JD, Barry MJ, Bruskewitz RC, et al. Benign Prostatic Hyperplasia: Diagnosis and Treatment. Clinical Practice Guideline, Number 8. AHCPR Publication No Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. February 1994. Ziada A, Rosenblum M, Crawford ED. Benign prostatic hyperplasia: an overview. Urology. 1999;53:1-6. AUA Guideline 2003/updated 2006.

Optional Diagnostic Tests
Following initial evaluation Uroflow Urinary flow-rate recording (Qmax) PVR If patient chooses invasive therapy Pressure flow Urethrocystoscopy Prostate ultrasound Optional tests may help in the decision making process when the initial evaluation suggests: Nonprostatic cause for the patient’s symptoms Patient selects invasive therapy Urinary flow-rate recording and measurement of post void residual urine (PVR) may be appropriate. These tests usually are not necessary prior to the institution of watchful waiting or medical therapy. However, they may be helpful in patients with a complex medical history ( i.e.., neurologic or other diseases known to affect bladder function or prior failure of BPH therapy) and in those desiring invasive therapy. If patient chooses invasive therapy Additional diagnostic tests may be helpful when outcome of the pressure-flow study may impact choice of intervention or if the prostate size and anatomical configuration are important considerations for a given treatment modality. Pressure Flow Urodynamic study: directly measures the relative contribution of the bladder and bladder outlet and the contributions of the prostate to lower urinary tract function, dysfunction or symptoms. Urethrocystoscopy: may guide the choice of therapy in patients who have already decided to proceed within invasive approach Transrectal or transabdominal prostate ultrasound: may guide choice of therapy based upon size and shape of the prostate AUA Guideline 2003/updated 2006.

Standard Questionnaires for Patient’s Perception of BPH Symptoms
AUA Symptom Score International Prostate Symptom Score (IPSS) BPH Impact Index (Bother Score) From the patient’s perspective, the morbidity of BPH is largely due to the symptoms of prostatism. BPH is associated with bothersome symptoms that can severely impact QOL, with effects on general health, physical well-being, and mental health. Instruments for evaluating symptoms and assessing their impact on QOL have been developed. Tools are not a replacement for personal discussion of symptoms with the patient. Tools for measuring symptoms include: AUA Symptom Score IPSS BPH Impact Index (Bother Score) Assessment of QOL

AUA Symptom Score Index
Seven-item questionnaire related to BPH symptoms Validated and reproducible Determines disease severity Documents response to therapy Allows standardized comparisons of symptom relief when evaluating treatments AUA Symptom Index and the identical IPSS. Validated, patient-administered, seven-item questionnaire that assigns a numerical value to symptoms and helps classify the disease for treatment planning and follow-up purposes. For quantification of symptoms, the preferred instrument is the patient-administered AUA Symptom Score Index. It contains seven questions related to BPH symptoms. It has been validated and is reproducible. References AUA Guideline 2003 McConnell JD, Barry MJ, Bruskewitz RC, et al. Benign Prostatic Hyperplasia: Diagnosis and Treatment. Clinical Practice Guideline, Number 8. AHCPR Publication No Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. February 1994. Barry MJ, Fowler FJ, O’Leary MP, et al. The American Urological Association Symptom Index for benign prostatic hyperplasia. J Urol : AUA Guideline 2003/updated 2006.

AUA Symptom Score AUA Guideline 2003/updated 2006.

Classification of AUA Symptom Scores
The possible total runs from 0-35 points with higher scores indicating more severe symptoms. Scores lower than 7 are considered mild and generally do not warrant treatment. Classification ranges Mild (0-7) Moderate (8-19) Severe (20-35) Without bother or bothersome AUA Guideline 2003/updated 2006.

Initial Management and Discussion Using AUA Symptom Score
Patients with mild symptoms (AUA symptom score ≤ 7) and Patients with moderate or severe symptoms (AUA symptom score ≥ 8) who are not bothered by their symptoms Offer watchful waiting Reassure patient Reassess periodically Using a scoring system, BPH symptoms experienced by the patient are classified as mild (score of 0–7), moderate (8–19), or severe (20–35), thus assigning severity to the disease. Although it should not be used as the sole means of diagnosis, the AUA Symptom Score Index can be used for treatment planning and follow-up. Depending on the score derived from the patient’s response to the index, the treatment approaches can be determined. Patient education materials can help patients make informed choices or discuss matters of concern with their doctors.

Initial Management and Discussion Using AUA Symptom Score
Patients with bothersome, moderate to severe symptoms (AUA Symptom Score ≥ 8) Watchful waiting Discuss BPH treatment options, including benefits and risks Provide patient education materials

International Prostate Symptom Score (IPSS)
AUA Symptom Score Index plus additional question on QOL as a function of urinary symptoms: “If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?” Scale of 0 to 6 (delighted to terrible) Note: While symptoms may be prevalent, they may not be troublesome The difference between the IPSS and the AUA Symptom Score Index is the one question on QOL that appears in the IPSS. The question asks patients to rate their QOL should their urinary symptoms persist and never change, thereby giving some idea of how troublesome or bothersome the symptoms are in relation to daily activities. Because patient tolerances to symptoms vary, clinicians should keep in mind that symptoms may be prevalent but not bothersome. IPSS was originally designed as a research tool but is among the best-known tools in the clinical arena for evaluating symptoms. O’Leary MP. LUTS, ED, QOL: alphabet soup or real concerns to aging men? Urology. 2000;56(suppl 5A):7-11. O’Leary MP. Urology

BPH Impact Index (Bother Score)
None Only a little Some A lot 1. Over the past month, how much physical discomfort did any urinary problems cause you? 2. Over the past month, how much did you worry about your health because of any urinary problems? Not at all Bothers Bothers Bothers bothersome me a little me some me a lot 3. Overall, how bothersome has any trouble with urination been during the past month? None of A little of Some of Most of All of the time the time the time the time the time The BPH Impact Index is shown on this slide. The BPH Impact Index measures the impact of symptoms on QOL, with assessment of physical discomfort, anxiety/worry, bothersomeness, and effect on activities of daily living. 1. Barry MJ, Fowler FJ Jr, O’Leary MP, et al, for the Measurement Committee of the American Urological Association. Measuring disease-specific health status in men with benign prostatic hyperplasia. Med Care. 1995;33(suppl 4):AS145-AS155. 2. O’Leary MP. LUTS, ED, QOL: alphabet soup or real concerns to aging men? Urology. 2000;56(suppl 5A):7-11. 4. Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you would usually do? AUA Guideline 2003/updated 2006.

Mechanism of Action

Definitions Current - the number or amount of electrons flowing past a fixed point for a fixed amount of time Current density - the amount of current flowing per unit area of a conductor surface Electricity - the flow of atoms through various mediums such as fluids or metals that are called conductors. There are negatively charged particles inside the atoms called electrons. The electrons will move through a conductor if force or pressure is applied.

Definitions - continued
Hyperthermia therapy - prostate tissue is heated to the range of 42 to 44 C. Tissue effect is temporary. Resistance/impedance - resistance encountered by the electrons as they move through a conductor. Resistance/ impedance is measured in ohms. Voltage - the force or pressure that moves electrons through a conductor.

Current Density

Basic Function The PROSTIVA® RF Therapy system generator produces the voltage (force) necessary to move the electrons through the prostate tissue to the grounding pad. Electrons moving through the tissue vibrate the tissue causing heat from friction. Temperature/time 45 C – 60 Minutes 55 C – 20 Minutes 60 C – 5 Minutes 70 C – 2 Minutes Boschef, et al. ASME, 2001.

Impact of Heat on Tissue
The heat generated in the tissue by the needles can be described as forming two zones. Pathological lesion Produced when temperatures reach > 55° C Described as coagulative necrosis (dead tissue surrounded by healthy tissue) Physiological lesion Occurs at temperatures > 47° C Surrounds the pathological lesion and is described as the gelatinized zone Tissue is not killed, but damaged Result is injury to the tissue that is accompanied with inflammation and edema, resembling a gel Boschef, et al. ASME, 2001.

Delivery of RF Energy Through Needles
RF energy disperses quickly and predictably in tissue. The energy creates heat through “cellular friction.” The heat created measures 115° C for PROSTIVA® RF Therapy at the center of the lesion (pathological lesion). The temperature of the heat drops between 5° to 15° C every 2 mm away from the needles (physiological lesion). Medtronic internal data on file.

Science Behind the Technology
Based on reasonable scientific analysis, PROSTIVA® RF Therapy works in the following ways: Denervation Devascularization

Denervation Alpha-receptors have the highest concentration at and around the bladder neck; alpha-blocker medications target this area. PROSTIVA® RF Therapy is the only therapy that delivers lethal, controlled doses of 115° C temperatures precisely to this area while protecting the bladder neck’s functionality. The system’s right angle delivery of the predetermined needle length and the known centimeter spheroid lesion size ensures this. The destruction of these alpha-receptor nerve fibers has been shown histologically. PROSTIVA RF Therapy Model 8930 System User Guide; 4-3. Perchino M. Eur Urol 1993.

Alpha Receptors in the Prostate

Devascularization Two main arteries which supply the prostate come in at 11 and 1 o’clock positions. The growth and proliferation of the abnormal cells requires blood flow in order to progress. The interference of the blood supply will impede the abnormal cellular activities within the transitional zone of the prostate. This can be influenced by creating lesions or scar tissue by delivering RF energy to this exact area.

Prostate Blood Supply

PROSTIVA® RF Therapy Procedure and Its Impact on Size
Recall that 5- reductase inhibitors block free testosterone from binding to 5- reductase PROSTIVA RF Therapy may kill: 5- reductase that is in the lesion The blood vessels that carry the free testosterone to the transitional zone PROSTIVA RF Therapy could decrease the size of the prostate

Mechanism of Action Animation
Click to play movie

MRI Movie Sequence Click to play movie
Used by permission - Thayne Larson, M.D.

MRI Lateral Lobe Lesions Coronal View
These MRI images were obtained by Dr. Thayne Larson one week after Medtronic RF therapy. The patients were injected with gadolinium contrast, which is shown as the bright areas in the MRI images. The lesions are depicted in the dark areas and indicate the absence of blood flow into those areas. Reference: Thayne Larson, M.D., Institute for Medical Research Used by permission - Thayne Larson, M.D.

MRI Lateral Lobe Lesions Horizontal View

MRI Median Lobe Lesions Coronal View

MRI Median Lobe Lesions Horizontal View

Treatment Options for Benign Prostatic Hyperplasia (BPH)

How do you balance the challenges of providing a good in-office experience versus long-term symptom relief for your patients?

What’s Your BPH Treatment Algorithm?

Treating BPH Minor symptoms usually do not require treatment.
Moderate to severe symptoms tend to interfere with sleep and daily activities and usually require treatment.

Three Categories of Treatment Options
Drug Therapy Office Procedure Surgical -blocker 5- reductase inhibitor Combination Radio Frequency High energy TUMT Low energy TUMT ILC TURP TUIP PVP HoLAP EXPLAIN DIFFERENCE BETWEEN HIGH ENERGY AND LOW ENERGY

Drug Therapy Advantages Disadvantages No surgery
Effective for mild to moderate symptoms Disadvantages Lifelong commitment to therapy Effectiveness may decrease over time Drug therapy can cause multiple side effects Impotence, dizziness, headaches, fatigue, and decreased libido Must take a daily pill for the rest of your life to maintain symptom relief and costs approximately $1,000 per year

Surgical – Transurethral Resection of the Prostate (TURP)
Advantages Availability of long-term outcomes data Good clinical results Treats prostates <150 g Low retreatment rate Low mortality Disadvantages Requires two to four days hospitalization Requires general or spinal anesthesia Potential surgical risks include: Impotence Retrograde ejaculation Incontinence Infection Excessive blood loss TURP offers several potential advantages for the treatment of BPH. First, it is associated with good clinical results. Indeed, with the possible exception of open prostatectomy, no other surgical modality has been shown to be its equal in terms of symptom improvement. TURP allows for treatment of glands with masses of up to 100 g; and the retreatment rates in patients who undergo TURP are low. One of the disadvantages of this procedure is its reliance on the skill of the individual surgeon. Moreover, although improvements in technology and technique have resulted in marked reductions in postoperative mortality and morbidity, postoperative bleeding and impairments in sexual function, such as retrograde ejaculation, are still disturbing complications of TURP. Borth CS, Beiko DT, Nickel JC. Impact of medical therapy on transurethral resection of the prostate: a decade of change. Urology. 2001;57: Debruyne FMJ, Djavan B, DeLaRosette J, et al. Interventional therapy for benign prostatic hyperplasia. In: Benign Prostatic Hyperplasia. 5th International Consultation on Benign Prostatic Hyperplasia (BPH). Eds: Chatelain C, Denis L, Foo KT, et al. World Health Organization–International Union Against Cancer. Paris, France. June 25-28, 2000: Mebust WK, Holtgrewe HL, Cockett ATK, Peters PC, for the Writing Committee. Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients. J Urol. 1989;141: Wagner JR, Russo P. Urologic complications of major pelvic surgery. Semin Surg Oncol. 2000;18: Borth CS et al, Urology, Mebust WK et al, J Urol, 1989. Wagner JR et al, Semin Surg Oncol, 2000.

Surgical - GreenLight PVP™
Hospital-based procedure Requires general anesthesia Better for smaller prostates TURP-like results

Holmium laser ablation of the prostate (HoLAP)
Surgical - HoLAP Holmium laser ablation of the prostate (HoLAP) Performed as an outpatient procedure Tissue ablation is roughly equivalent to GreenLight PVP™ Versatility of performing across multiple specialties and treating other urology conditions including strictures, tumors and stones

Avoid the need to take daily medication
Office Procedures Avoid the need to take daily medication Avoid some of the risks and complications associated with surgery

Radio Frequency Therapy (PROSTIVA®) Microwave Thermotherapy (TUMT)
Office Procedures Radio Frequency Therapy (PROSTIVA®) Microwave Thermotherapy (TUMT) Interstitial Laser Coagulation (ILC) Definitions – ILC definition

Office Procedure - TUMT
Microwaves used to heat and destroy excess prostate tissue Procedure takes about one hour Some require 2 to 14 days of catheterization which can result in urinary tract infection

Office Procedure - ILC Laser energy coagulates obstructing tissue of the enlarged prostate gland The tissue that is destroyed is absorbed by the body and BPH symptoms decrease over time May require extended post-procedural catheterization which can result in higher rates of urinary tract infection Procedure takes less than one hour Requires 5 to 14 days of catheterization

PROSTIVA® RF Therapy Indication for Use
PROSTIVA® Radio Frequency Therapy 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 cm3. PROSTIVA® RF Therapy System User Guide.

PROSTIVA® RF Therapy Delivers low-level radio frequency energy into the middle of the prostate and relieves obstruction without causing damage to the urethra Can be performed with a sedative and local anesthetic in a urologist’s office Procedure takes less than one hour Catheterization, if required, is 0-2 days on average Intended for men over age 50

Temperature Chart Prolieve, Prostatron, Thermatrx, Targis, Indigo Instructions for Use. PROSTIVA RF Therapy System User Guide.

What Side Effects are Associated with PROSTIVA® RF Therapy?
Possible side effects include: Obstruction Catheterization (for urinary retention) Bleeding/blood in urine Pain/discomfort Urgency to urinate Increased frequency of urination Urinary tract infection Patients may also experience a minor burning sensation when urinating for one to two weeks following the treatment Compared to traditional surgical treatments, fewer side effects and adverse events PROSTIVA RF Therapy side-effects/adverse events include obstruction, catheterization, bleeding, pain/discomfort, urgency, frequency and urinary tract infection Possible side effects include: Obstruction, bleeding, blood in urine, pain/discomfort, urgency to urinate, increased frequency of urination and urinary tract infection. Patients may also experience a minor burning sensation when urinating for one to two weeks following the treatment. PROSTIVA® RF Therapy System User Guide.

PROSTIVA® RF Therapy Overview

Nearly 100,000 patients treated worldwide Five-year efficacy data
Proven RF Technology Nearly 100,000 patients treated worldwide Five-year efficacy data After five years: IPSS - 55% Qmax +29% QOL +68% 115º C core lesion temperature 89 published articles on RF therapy for BPH Hill, et al, J Urol, 2004.

Precise Therapy Delivery
360 degrees of precision to treat exactly the area you want Six different needle length options to treat varying prostate sizes and shapes 15 computer-monitored safety checks

Evolution of RF Therapy
1992 TUNA 3 min Lesion (manual) Catheter – 22F 26 gauge needles Manual power, impedance and temperature controls Physician dependent 1997 2000 2003 2006 ProVu 5.5 – 7 min lesion ProVu Delivery System Precision 4 min lesion Precision Plus 3 min lesion PROSTIVA 2 min 20 sec lesion First automatic system models 7205 & 7600 18.5F/26 gauge needles Temperature measured by shield thermocouples 18.5F delivery system Highest quality optics with proximal and distal positioning 6 preset needle lengths Automatic shield deployment Urethral thermocouple Reusable handle w/ disposable cartridge Target temperature of 110° C Hollow tip needles Thermocouples in shields and both needle tips Shield length = 6mm Designed for office Lesion time 25% faster than Precision Larger needle (24 gauge) provides for consistent heating in all types of tissue New RF generator Lesion time 22% faster than Precision Plus Target temp of 115 ° C Integrated disposable hand piece

PROSTIVA® RF Therapy Designed by Medtronic
Target lesion temperature of 115°C 2 min 20 second per lesion Easy set-up User interface with touch screen controls Platform of the future Designed and built by Medtronic from the ground up, this is our new generator.

PROSTIVA® RF Therapy System Components

Generator Features Computer Monitored Safety Checks:
Monitors urethral and prostatic temperatures six times per second Controls RF power 5000 times per second Measures impedance and power 50 million times per second Computerized graphics allow physician to view treatment in real time Designed and built by Medtronic from the ground up The PROSTIVA generator is fast and easy to use -- features effectiveness, and safety that physicians have grown accustomed to. This is the platform for the Future – upgradeable.

Hand Piece Features Single sterile use
Tubing system connects to hand piece Tubing connects to an irrigation source which supplies cooling fluid during procedure

Telescope Features Reusable, but must be cleaned and sterilized before each procedure Allows physician to directly view anatomical landmarks and the needle deployment site Both 0º and 15º telescopic angles available

Patient Selection and Assessment

Examples of prostate shapes that PROSTIVA® RF Therapy can treat
Patient Selection Examples of prostate shapes that PROSTIVA® RF Therapy can treat 20-50 grams Long Lobes Short Lobes Asymmetric Gland Median Lobe* PROSTIVA RF therapy treats the median and lateral lobe as well as asymmetrical prostates. With an exception of the median lobes that protrude into the bladder and collapse over the bladder neck. *Excluding a ball valve median lobe that grows up into bladder and obstructs opening

Contraindications Patients with active urinary tract infection
Neurogenic, decompensated, or atonic bladder Urethral strictures or muscle spasms that prevent insertion of the hand piece sheath Bleeding disorders or patients taking anticoagulation medications 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 Prostate gland <34 mm or >80 mm in transverse diameter Presence of any prosthetic device in the region that may interfere with the procedure Patients whose prostate has been previously treated with non-pharmacological therapies Presence of a cardiac pacemaker, implantable defibrillator, or malleable penile implants Patients with any component(s) of an implantable neurostimulation system

PROSTIVA® RF Therapy Procedure Basic Steps

PROSTIVA® RF Therapy Procedure
Prepare patient Administer comfort control Measure prostate Determine number of treatment planes Treat median lobe if necessary Create lesions

Comfort Control Protocol
Describe your comfort control protocol See Medtronic PROSTIVA® RF Therapy procedural video for several comfort control options, which can be used during the PROSTIVA RF procedure. Medical practice is solely the responsibility of the individual physician and not Medtronic.

Treatment Approach Guidelines for determining the number of treatment planes are based on the distance from the bladder to the verumontanum Ideally, a minimum of two planes should be treated, provided that the distance from the needle placement to the bladder neck and from the needle placement to the veru remains cm A treatment plane consists of delivery of energy to the right and left lobes at the same level Determination of the number of treatment planes is the clinician’s sole medical judgment. PROSTIVA® RF Therapy System User Guide.

Determining Number of Treatment Planes
Recommended guidelines PROSTIVA® RF Therapy System User Guide.

Median Lobe Treatment Visualize size and structure
Needles should be deployed 1 cm away from the proximal margin of the bladder neck Select needle length of 12 or 14 is recommended Determination of median lobe treatment locations and appropriate needle length is the clinician’s sole medical judgment. PROSTIVA System User Guide PROSTIVA® RF Therapy System User Guide.

Median Lobe Treatment Locations
Recommended treatment locations Proximal (upper) end 10, 12, and 2 o’clock Distal (lower) end 6 o’clock location is for therapy at distal end PROSTIVA® RF Therapy System User Guide.

PROSTIVA® RF Therapy Procedure

Prostate During Procedure

Prostate Post-Procedure

MRI Image Post-Procedure
Click on picture to show MRI image

Reimbursement

Reimbursement Status PROSTIVA® RF Therapy coverage:
Medicare in all 50 states Many private pay and managed care insurance companies Most patients will be responsible for a deductible and/or co-payment Medicare reimburses physicians for performing the PROSTIVA RF Therapy procedure in their offices (there is a site of service differential)

Clinical

Outcomes Would you perform the PROSTIVA® RF Therapy procedure on your father? Why do you think PROSTIVA RF Therapy works?

PROSTIVA® RF Therapy Long-term Durability
Can you speak to long-term durability? Hill B, Belville W, Bruskewitz R, Issa M, Perez-Marrero R, Roehrborn C, Terris M, Naslund M, “Transurethral Needle Ablation versus Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results of a Prospective, Randomized, Multicenter Clinical Trial,” J Urol, 2004;171: Zlotta, AR, Giannakopoulos X, Maehlum O, Ostrem T, Schulman CC, “Long-Term Evaluation of Transurethral Needle Ablation of the Prostate (TUNA) for Treatment of Symptomatic Benign Prostatic Hyperplasia: Clinical Outcome Up To Five Years From Three Centers,” Eur Urol, 2003; 44:89-93 Boyle P, Robertson C, Vaughan E D, Fitzpatrick J, “A Meta-Analysis of Trials of Transurethral Needle Ablation for Treating Symptomatic Benign Prostatic Hyperplasia”, British Journal of Urology Intl, 2004; 94: AUA Guidelines 2004, “Management of Benign Prostatic Hyperplasia: Diagnosis and Treatment Recommendations” Chapter 1, page 27.

References Issa M, Marshall F. Contemporary Diagnosis and Management of Diseases of the Prostate. 3rd ed. Newtown, Pa: Handbooks in Healthcare Co; 2005. American Urological Association Education and Research, Inc. AUA Guideline 2003/Updated 2006. O’Leary MP. LUTS, ED, QOL: alphabet soup or real concerns to aging men? Urology, 2000;56(suppl 5A):7-11. Boschef, et al., “In vitro assessment of the efficacy of thermal therapy in human benign prostate hyperplasia,” ASME, 2001 Nov; 2001. PROSTIVA RF Therapy Model 8930 System User Guide, 4-3. Perchino M, et al., “Does transurethral thermotherapy induce a long-term alpha blockade? An immunohistochemical study,” Eur Urol, 1993, 23: Larson, Thayne. Institute of Medical Research and Lance Mynderse, M.D., Mayo Clinic. “MRI study of 12 patients with average age of 64, treatment focus on bladder neck and lateral lobe,” 2006 Medtronic RF Therapy Study. Accessed March 7, 2006. PROSTIVA® RF Therapy System User Guide. Safety information from System User Guide is available at

References Hill B, Belville W, Bruskewitz R, Issa M, Perez-Marrero R, Roehrborn C, Terris M, Naslund M, “Transurethral Needle Ablation versus Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results of a Prospective, Randomized, Multicenter Clinical Trial,” J Urol, 2004;171: Nickel JC, “Long-term implications of medical therapy on benign prostatic hyperplasia end points,” Urology, 1998;51(suppl 4A):50-57. Borth CS, Beiko DT, Nickel JC, “Impact of medical therapy on transurethral resection of the prostate: a decade of change,” Urology, 001;57: Mebust WK, Holtgrewe HL, Cockett ATK, Peters PC, for the Writing Committee. “Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients,” J Urol, 1989;141: Wagner JR, Russo P, “Urologic complications of major pelvic surgery,” Semin Surg Oncol, 2000;18: For more information about PROSTIVA® RF Therapy, call (800) , x6000; or visit CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Anatomy and Physiology

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Anatomy and Physiology

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Presentation on theme: "Anatomy and Physiology"— Presentation transcript:

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About project

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