Instructions for Use
Contents
1. accordance with international standard DIN VDE 0107 and the national standard ANSI NFPA 70 The equipment must be connected to a fully tested hospital grade power outlet with adequate grounding The Control Unit must be plugged into the appropriate voltage outlet The electrical equipment inside the Targis System uses voltages which are capable of causing serious injury or death from electric shock To avoid this hazard operators must never open the housing of the Control Unit Power Requirements Supply European Version 220 240 V 10 8A Single phase 50 or 60 Hz US Version 110 120 V 10 15A Single phase 50 or 60 Hz Japanese Version 100 V 10 15A Single phase 50 or 60 Hz Connections Hospital Grade plug For further safety information refer to the TARGIS SYSTEM USER MANUAL The safety and effectiveness of the Cooled ThermoTherapy procedure has not been established in patients with the following conditions e Clinical or histological evidence of prostatic cancer or bladder cancer e Interest in the preservation of future fertility e Post Void Residual PVR gt 350 mL e Previous pelvic surgery e Previous rectal surgery other than hemorrhoidectomy Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder sometimes referred to as a ball valve median lobe Active urinary tract infection Gross hematuria not due to BPH Prior prost2. case of pain or discomfort during sexual activity urgency nocturia and urethral strictures the rates for the Targis Microwave Catheter 28 5 minute treatment and the Cooled ThermoCath Microwave Catheter 28 5 minute treatment are very similar to the original clinical study data Cooled Targis Targis ThermoCath 60 min_ 28 5 min 28 5 min Post treatment catheterization o1 in 89 6 100 0 8 9 10 4 0 1 4 days 62 2 62 5 45 0 5 7 days 15 6 12 5 275 8 27 days 13 3 14 6 27D Hematuria 65 2 58 3 59 0 Dysuria 47 8 52 1 23 155 Clots in urine 47 8 43 8 43 5 Temporary or partial ejaculate loss 45 7 20 8 5 1 Pain or irritation in the groin or pelvis 41 3 31 3 1 720 Bladder spasms 39 1 33 370 5 1 Hemospermia 32 6 22 9 7 7 Prostatic urethra damage 30 4 20 8 13 5 Rectal irritation 23 9 39 6 17 9 Temporary incontinence 21 7 14 6 12 8 Interrupted flow 13 0 18 8 7 7 Sensation of not emptying bladder 13 0 16 7 5 1 Bladder trabeculation 10 9 6 3 18 9 Severe pain during treatment 8 9 2 1 2 5 ha discomfort during sexual 8 7 14 6 7 7 Frequency 8 7 4 2 2 6 Hesitancy 6 5 18 8 2 6 Urgency 6 5 10 4 5 1 Post void dribbling 6 5 10 4 O a A changes during 6 5 2 1 0 Hie dancin in general related to 6 5 0 0 Transient erectile dysfunction 4 3 12 5 10 3 Urinary tract infection 4 3 8 3 O Complete
3. com 2013 Urologix Inc All rights reserved Printed in U S A 250348 Rev E 11 13
4. urine flow rates The multiple U S clinical studies which include 152 patients at 6 month follow up show that 79 of the Targis System treated patients experienced symptom improvement greater than 25 and that 59 experienced improvement greater than 50 The mean improvement in AUA Symptom Score was 51 With regard to uroflometry 66 of the patients demonstrated improvements in peak flow rate of greater than 25 The mean change in peak flow rate was 4 1 mL s a 53 increase over baseline In a randomized and blinded study patients who received an active treatment exhibited significantly greater improvements in symptom score than sham treated patients p 0 011 Patients who received an active treatment also exhibited significantly greater improvements in peak flow than sham treated patients p 0 002 One hundred and seven patients have matched data on AUA Symptom Score from baseline to one year follow up The mean symptom improvement in this patient group was 10 2 points 51 Eighty nine patients have matched data on peak flow from baseline to one year follow up Mean peak flow improvement in this patient group was 3 8 mL s 49 Significant improvements were seen in additional measured parameters of Quality of Life Symptom Problem Index SPI and the BPH Impact Index BII All improvements remained stable through one year follow up These improvements are consistent with additional data collected from international studies on over 111 patient
5. 6 TEMPERATURE SENSORS HANDLE ORIENTATION FLAG FINGER PAD RECTAL BALLOON Coolant Bag CONNECTOR EXTENSION TUBING BALLOON INFLATION PORT The Coolant Bag is used as a reservoir for sterile water which during treatment is chilled and circulated through the CTC Advance Microwave Catheter by the Control Unit to protect the urethra from heat generated by the CTC Advance Microwave Catheter The Cooant Bag is comprised of three 3 main subassemblies coolant reservoir sensor module and tubing with connectors The coolant reservoir is a polymer bag that is filled with sterile water The coolant reser voir mates with the chill plate of the Control Unit to remove heat generated by the CTC Advance Microwave Catheter during the Cooled ThermoTherapy procedure The sensor module pressure and temperature windows mate with corresponding measurement devices on the Control Unit The sensor module works in communication with the Control Unit to allow pressure and temperature to be monitored during the Cooled ThermoTherapy procedure The Control Unit uses this information to monitor these parameters during the entire Cooled ThermoTherapy procedure The inlet and outlet tubing connectors mate with the connectors of the CTC Advance Microwave Catheter to establish a closed loop coolant system involving the Coolant Bag and the CTC Advance Microwave Catheter COOLANT BAG MOUNTING RESERVOIR HOLE HYDROPHOBIC MOUNTING P HOLE C
6. CTC Advance Instructions for Use Targis System Control Units Model 4000 Series and Model 5000 Series CTC Advance Microwave Catheter Rectal Thermosensing Unit RTU Coolant Bag CAUTION Federal U S A law restricts this device to sale by or on the order of a physician trained and or experienced in the use of this device as outlined in the required training program CAREFULLY READ AND UNDERSTAND ALL INSTRUCTIONS INDICATIONS WARNINGS PRECAUTIONS AND DIRECTIONS FOR USE PRIOR TO USING ANY TARGIS SYSTEM COMPONENT OR THE CONTROL UNIT FAILURE TO DO SO COULD RESULT IN COMPROMISED PATIENT SAFETY PATIENT COMPLICATIONS AND OR INSUFFICIENT TREATMENT Indications for Use The Targis System is a non surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia BPH and is indicated for men with prostatic urethra lengths of 2 5 3 5 cm model number TH1321C 3 0 5 0 cm model number TC1121C or 4 5 cm model number TF1221C 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 the CTC Advance 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 CTC Advance Microwave Catheter
7. OOLANT FEMALE VENT OUTLET TUBING LUER MOUNTING HOLE COOLANT Control Unit CONNECTOR P TA Sa COOLANT INLET AND OUTLET TUBING So SENSOR INLET TUBING MODULE MALE LUER CONNECTOR The Control Unit is used to provide and control energy generation and safety for the Cooled ThermoTherapy pro cedure The Control Unit includes a computer microwave energy source coolant system fiber optic temperature monitoring system and software These systems are integrated to precisely and continuously monitor all aspects of a Cooled ThermoTherapy procedure including energy generation and delivery coolant temperature and the user interface to provide safety shutdowns when procedural and patient safety issues are detected The Control Unit also maintains a procedural file on the parameters of treatment for an individual patient and procedure MICROWAVE POWER INDICATOR SOFT KEYS MAIN POWER INDICATOR Tg PATIENT CONNECTION CABLE FLOPPY DISK DRIVE Accessories Several accessories accompany the Targis System They include e Targis System Users Manual e Control Unit Dust Cover e Patient Comfort Kit containing 2 Knee Cushions and an CTC Advance Holder e Patient Cable Holder e An optional Transport Kit containing a Trolley Protective Cover and Electrical Safety Tester REFER TO THE TARGIS SYSTEM USER MANUAL FOR SPECIFIC AND COMPLETE INSTRUCTIONS FOR THE OPERATION STEPS AND PROTOCOL ENSURE
8. PATIENT HAS RECEIVED AN EFFECTIVE ENEMA WITHIN 2 HOURS PRIOR TO INITIATION OF TREATMENT How Supplied All components of the CTC Advance Microwave Catheter Procedure Kit are intended for one time use only DO NOT resterilize and or reuse them as this will likely result in compromised device performance and increased risk of injury or infection to a patient and treating staff The CTC Advance Microwave Catheter Procedure Kit components are supplied in sterile double barrier packaging that has been exposed to ethylene oxide The CTC Advance Microwave Catheter Procedure Kit and components are placed in shelf boxes with tamper proof labels DO NOT USE COMPONENTS THAT HAVE EVIDENCE OF A COMPROMISED PACKAGE OR DAMAGE Store in ambient conditions between 59 95 F 15 35 C Restricted Devices The CTC Advance Microwave Catheter Procedure Kit its components and the Control Unit are intended for urological use only in the treatment of patients suffering voiding difficulties secondary to BPH Candidates for Cooled ThermoTherapy procedure require careful consideration The CTC Advance Microwave Catheter Procedure Kit components must not be used with any other system 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 Warranty and Limitations Urologix Inc warrants that each component of this device has been manufactured pack
9. The CTC Advance Microwave Catheter is used as part of the Targis System to treat men with prostatic urethra lengths as indicated on the microwave catheter label and as measured from the bladder neck to the verumontanum Contraindications for the Cooled ThermoTherapy Procedure e Patients with a prostatic urethra lt 2 5 cm in length as measured from the bladder neck to the verumontanum e Patients with urinary sphincter or any implant metallic or non metallic which is within 1 5 inches 38 mm of the prostatic urethra e Patients with urethral stricture unable to pass 22 F urethroscope e Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome i e claudication of the buttocks or perineum e Patients who have undergone pelvic radiation therapy e Patients with implanted active devices including pacemakers or defibrillators within 2 6 inches 6 5 cm of the prostatic urethra Warnings The Cooled ThermoTherapy procedure has inherent associated risks of complications refer to Adverse Events and Complications 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 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 Selection and use of the appropriate catheter mode
10. aged and tested with reasonable care and will be free from defects in workmanship and material Urologix will not be liable for any incidental special or consequential loss damage or expense direct or indirect from the use of its product Urologix sole obligation shall be to repair replace at its option any device that we feel was defective at time of shipment if notice thereof is received within one year of shipment Buyer assumes all liability whether arising on warranty contract negligence compliance with all local laws and regulations which govern the use and sale of this device or otherwise for damages resulting from the handling possession use or misuse of the product Because Urologix has no control over the operation inspection maintenance or use of its products after sale and has no control over the selection of patients THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY OTHER EXPRESSED OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE AND OF ANY OTHER OBLIGATION ON THE PART OF THE SELLER If the user is located outside the United States Urologix invokes all oral or written expressed or implied warranty limitations legally permissible in that jurisdiction The remedies set forth in the above Warranty and Limitations shall be the exclusive remedy available to any person No agent employee or representative of Urologix has any authority to change any of the foregoing or assume or bind Urologix to any additional lia
11. as the 28 5 minute treatment with the Targis Microwave Catheter The long term 12 month safety and effectiveness of the Cooled ThermoCath Microwave Catheter 28 5 minute treatment has not yet been established This data will be provided when available From the current data available for the Cooled ThermoCath Microwave Catheter clinical investigation it is not possible to identify any characteristics that are associated with a more favorable response Treatment with the Targis Microwave Catheter at 28 5 minutes and 60 minute intervals and the Cooled ThermoCath Microwave Catheter at 28 5 minutes are effective and clinically relevant procedure options Information for Patients Physicians should inform patients that an inherent risk of complications is associated with the Cooled ThermoTherapy procedure refer to Adverse Events and Complications Physicians should inform patients that loss of ejaculation may occur as a result of the Cooled ThermoTherapy procedure and thus should be considered by men who may wish to have further offspring Physicians should inform patients that the volume of ejaculate may be decreased in some men who undergo the Cooled ThermoTherapy procedure Temporary acute urinary retention temporary incontinence minimal bleeding pain during urination and intercourse and urinary tract infection may be associated with the Cooled ThermoTherapy procedure The patient should be informed that a small risk of urethral stricture may res
12. atic surgery excluding balloon dilatation Coexisting illness or specific obstructive symptoms found to be caused by any of the following conditions Neurologic bladder disorders Bladder stones Prostate volume greater than 100 cc Evidence of bacterial prostatitis Bladder neck contracture Renal impairment Urinary sphincter abnormalities Coagulation disorders A thorough physical exam should be performed on patients prior to initiation of the Cooled ThermoTherapy procedure Patients who have received Cooled ThermoTherapy should be followed on an annual basis since the procedure does not result in complete destruction of the prostate The prostate specific antigen PSA levels will increase significantly following treatment This increase can be up to 10 times 1000 percent higher at 1 week and will decrease back to approximate normal levels by 6 weeks following the Cooled ThermoTherapy procedure The use of PSA testing during this period will be unreliable Physicians are cautioned to measure the serum PSA level before treatment for future comparisons PSA levels should return to baseline by 3 months following the Cooled ThermoTherapy procedure and may once again be used as a diagnostic test Attention by a qualified physician is required during the use of the Targis System The Control Unit display must be monitored and controlled during the course of a treatment session to make sure that the CTC Advance Microwave Catheter and rectal temperatur
13. bility or responsibility in connection with this device References 1 Paul D Miller Keith Parsons Ernest Ramsey Transurethral Microwave Thermoablation TUMT for Benign Prostatic Hyperplasia Using a New Device T3 Presented at the 90th Annual Meeting of the AUA Las Vegas NV April 1995 2 Ramsey E W Miller P D Parsons K Transurethral Microwave Thermotherapy in the Treatment of Benign Prostatic Hyperplasia Results obtained With the Urologix T3 Device World Journal of Urology 1998 16 3 Larson T R Bostwick D G Corica A Temperature Correlated Histopathologic Changes Following Microwave Thermoablation of Obstructive Tissue in Patients with Benign Prostatic Hyperplasia Urology 1996 47 4 463 469 4 Larson T R Blute M L Tri J L Whitlock S V Contrasting Heating Patterns and Efficacy of the Prostatron and Targis Microwave Antennae for Thermal Treatment of Benign Prostatic Hyperplasia Urology 51 6 1998 5 Djavan B Larson T R Blute M L Marberger M Transurethral Microwave Thermotherapy What Role Should it Play Versus Medical Management In the Treatment of Benign Prostatic Hyperplasia Urology 52 6 1998 The Targis System was formerly known as the T3 System during its development and clinical trials de 6 Urologix Inc Emergo Europe 14405 21st Avenue North Molenstraat 15 Minneapolis Minnesota 55447 USA 2513 BH The Hague 888 229 0772 The Netherlands 24 hour customer service www urologix
14. ee that operation of other devices will not be impacted The effect of this electromagnetic energy on all equipment can not be predicted due to age and quality of maintenance The performance of each piece of equipment operated near the Targis System during a procedure must be evaluated for degradation Since microwave energy can travel through walls ceilings and floors to affect other devices it is important to understand that the 1 meter safety distance applies not only to the treatment room but also to all adjacent rooms in the building including the rooms above and below the treatment room Do not operate the Targis System near equipment that emits electromagnetic energy unless the effect on the Targis System has been evaluated and no degradation of performance was found The national standard ANSI IEEE C95 1 1995 Edition Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields recommends a maximum stray field exposure level for whole body exposure of 3 mW cm as averaged for any six minute period The maximum radiated field at full power from the Control Unit patient cable and catheter at five centimeters is 2 1 mW cm Urologix recommends that the operator maintain a minimum distance of five centimeters from the patient cable and exposed portions of the catheter during the procedure Operate the Control Unit and connected devices only in clinical environments where the electrical installation is in
15. es are within prescribed treatment parameters Failure to monitor and deliver the Cooled ThermoTherapy procedure per recommendations by Urologix may lead to decreased patient safety and or reduced clinical effectiveness The CTC Advance Microwave Catheter and coolant bag are intended for one time use only DO NOT re sterilize and or reuse them as this will likely result in compromised device performance and increased risk of injury or infection to a patient Targis System components must not be used with any other system Do not use the CTC Advance Microwave Catheter if it appears to be damaged Use the CTC Advance Microwave Catheter prior to the use before date specified on the package Care should be taken in handling all components of the Targis System to avoid damage that may lead to subsequent failure of the component or procedure Because the Cooled ThermoTherapy procedure elevates intraprostatic tissue temperature causing tissue damage that may result in acute urinary retention the patient may be catheterized for 2 to 5 days median 3 days following the procedure and it is advisable that anti inflammatory and antibiotic medications be prescribed for 3 5 days As patient responses to the Cooled ThermoTherapy procedure are variable the patient should be evaluated by their physician following treatment Failure to maintain the equipment may result in exposure of the patient and or the operator to excessive microwave energy Adver
16. l is required to assure patient safety The Cooled ThermoTherapy procedure must not be initiated without assurance that the CTC Advance Microwave Catheter is properly positioned in the patient The correct positioning of the CTC Advance Microwave Catheter must always be checked by ultrasound imaging prior to commencing treatment Improper placement or orientation of the CTC Advance Microwave Catheter may lead to procedure failures or heating damage of non target tissues such as the bladder neck external sphincter or penile urethra 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 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 If possible active implanted devices that must remain ON should be programmed to the bipolar configuration Implanted cardioverter defibrillators should be set to monitor only mode during therapy Regardless of whether active implanted devices gt 2 6 inches 6 5 cm from the prostatic urethra can be turned OFF the patient should be monitored during the Cooled ThermoTherapy procedure f
17. loss of ejaculate 4 3 2 1 10 3 Bladder diverticuli 2 2 2 1 2 7 Weak stream 2 2 2 1 5 1 Persistent erectile dysfunction 2 2 O 2 6 Epididymitis 2 2 0 2 6 Difficulty ejaculating 0 0 2 6 Prostatitis 2 2 O O Nocturia 0 6 3 2 6 Urethral stricture 0 2 1 0 Rectal Fistula T T t tAlthough not observed in clinical studies isolated incidences of rectal fistula have been reported to Urologix Inc following Targis product commercialization It is believed that the incidence of this serious complication can be minimized through careful patient selection and strict adherence to the treatment instructions described in the Instructions For Use Events which were temporary or minor requiring minimal or no medical intervention A Clinical Summary The CTC Advance Microwave Catheters Models TH1321C TC1121C and TF1221C are modified versions of the Targis Microwave Catheters Models TA1321D and TA1121D and Cooled ThermoCath Microwave Catheters Models TC1121A and TF1221A Since extensive clinical data with the CTC Advance Microwave Catheter are not yet available the effectiveness outcomes associated with the Targis Microwave Catheter and Cooled ThermoCath Microwave Catheter are presented for reference PMA Submission Data for the Targis Microwave Catheter TA1121D Follow up on patients treated with the Targis Microwave Catheter demonstrated that this device is associated with significant improvements in BPH symptoms and
18. or possible interactions In the unlikely event of an active implanted device programming change the device should be interrogated following treatment with the Targis System 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 Use of the Targis System results in the deposition of microwave energy within the patient s prostate and in adjacent regions of the body Some animal studies in the literature suggest that there may be as yet unknown health effects from exposure to microwave radiation including an increased incidence of tumors Although it is not possible to extrapolate these studies to humans they suggest that unnecessary microwave radiation exposure should be avoided At least 20 cm of ventilation clearance must be provided around the base of the Control Unit The Targis System emits a small amount of electromagnetic energy during a procedure Urologix recommends that all electronic medical devices be kept at a minimum distance of 1 0 meter from the Targis System when performing a treatment However a 1 meter separation of electronic medical equipment from the Targis System does not guarant
19. rol Unit intended for the treatment of symptomatic and obstructive Benign Prostatic Hyperplasia BPH and its associated voiding difficulties All components must be in place with the Control Unit to begin a Cooled ThermoTherapy procedure The Targis System is a non surgical device intended to relieve symptoms associated with BPH and is indicated for men with prostatic urethra lengths of at least 2 5 cm as measured from the bladder neck to the verumontanum For complete and detailed instructions refer to the Targis System User Manual CTC Advance Microwave Catheter The CTC Advance Microwave Catheter is a catheter based system that includes a fiber optic temperature sensor microwave antenna and cable coolant channels and connectors urine drainage channel and a distal balloon for placement The CTC Advance Microwave Catheter is designed to deliver microwave energy to the target prostatic tissue while at the same time cooling and protecting the urethra The fiber optic sensor in the CTC Advance Microwave Catheter monitors the urethral temperature and is used to determine the amount of energy delivered during a procedure In the event that CTC Advance Microwave Catheter temperature rises above 44 5 C the Control Unit will discontinue microwave energy delivery to the CTC Advance Microwave Catheter For the Cooled ThermoTherapy procedure the CTC Advance Microwave Catheter is placed in the patient s urethra with the tip and balloon in the bladder and it i
20. s anchored into place with the 10 cc balloon The CTC Advance Microwave Catheter is oriented with the coolant tubing in the anterior direction Microwave energy is transmitted from the Control Unit to the CTC Advance Microwave Catheter antenna and directed into the prostate The microwave energy generates heat in the prostate that causes tissue necrosis which when resolved can improve the patient s symptoms flow rate and quality of life associated with BPH LUERS __s A BALLOON INFLATION Y PORT COOLING CHANNEL MICROWAVE ANTENNA CONNECTOR COUDE TIP L j TEMPERATURE birama SENSOR ja CONNECTOR URINE DRAINAGE FITTING LOCATION BALLOON RTU The RTU is a catheter based system that incorporates a compliant balloon and temperature sensors used to monitor the patient s rectal temperature during a Cooled ThermoTherapy procedure The RTU is placed in the patient s rectum prior to a Cooled ThermoTherapy procedure and left in place for the duration of the procedure In the event that rectal temperatures are raised above 42 5 C the RTU will signal the Control Unit to discontinue microwave energy delivery to the CTC Advance Microwave Catheter The RTU can be provided as a single use disposable device or provided in a configuration that will facilitate the cleaning and disinfection for multiple up to 30 treatments Refer to the Targis System User Manual for more detailed information for the use of the RTU
21. s at one year follow up Targis Microwave Catheter 28 5 minute vs 60 minute study data A randomized study comparing a 28 5 minute treatment to a 60 minute treatment was conducted enrolling 48 and 46 patients respectively The table below summarizes the 6 month results of 44 patients followed under the Targis Microwave Catheter Express protocol 28 5 min and 39 patients followed under the Targis Microwave Catheter Standard protocol 60min Follow up at 6 months indicate that both of the treatment groups demonstrated significant improvement from baseline p value lt 0 002 in all cases in their AUA Symptom Score Peak Flow Rate and Quality of Life Targis Targis Outcome Measurement 60 minute 28 5 minute results results Pre treatment AUA Symptom Score 21 0 22 1 AUA Symptom Score at 6 months 8 0 12 5 Pre treatment Peak Flow Rate 8 7 ml sec 8 7 ml sec Peak Flow Rate at 6 months 13 7 ml sec 11 1 ml sec Pre treatment Quality of Life 4 1 4 1 Quality of Life at 6 months 1 4 2 4 Alternative Surgical Treatment at 6 mo 2 2 0 Cooled ThermoCath Microwave Catheter 28 5 minute study data A prospective single center study was undertaken to evaluate the safety and efficacy the Cooled ThermoCath Microwave Catheter at 28 5 treatment Forty one 41 patients were enrolled in the study Forty 40 patients were treated Follow up at 6 months indicates that the preliminary data on this treatment demonstrates that it is at least as safe and effective
22. se Events and Complications with Cooled ThermoTherapy The CTC Advance Microwave Catheters Models TH1321C TC1121C and TF1221C are modified versions of the Targis Microwave Catheters Models TA1321D and TA1121D and Cooled ThermoCath Microwave Catheters Models TC1121A and TF1221A Since extensive clinical data with the CTC Advance Microwave Catheters are not yet available adverse events observed with the Targis Microwave Catheters and Cooled ThermoCath Microwave Catheters are presented for reference and comparison Most complications occurred shortly after treatment and were transient In the United States multi center prospective studies of the Cooled ThermoTherapy procedure were conducted using the Targis Microwave Catheter 206 patients were treated and followed for complications complaints and observations The following table shows the clinical adverse events and complications that were possibly probably and definitely related to the Cooled ThermoTherapy procedure An asterisk denotes events which were temporary or minor requiring minimal or no medical intervention Study investigators were required to notify Urologix of any complications which may have developed as a direct result of the Cooled ThermoTherapy procedure The following table is for the patients in the 60 minutes vs the 28 5 minute study using the Targis Microwave Catheter and for patients treated using the Cooled ThermoCath Microwave Catheter 28 5 minute treatment In the
23. ult from the Cooled ThermoTherapy procedure requiring further intervention refer to Adverse Events and Complications Patients may likely be catheterized for a 2 to 5 day median 3 day period following the procedure Patients may be prescribed anti inflammatory and antibiotic medications for a period following the procedure Patient should be informed that they may experience discomfort during the procedure that may require the use of analgesics or sedatives to deliver an effective treatment Product Description The Targis System utilizes proprietary microwave technology to deliver thermal energy into the prostate within the axis of the CTC Advance Microwave Catheter antenna This allows the Targis System to deliver energy continuously with minimal concern of treatment limiting shutdowns from rectal and urethral alarms Thus the Targis System can selectively generate and maintain peak intraprostatic tissue temperature levels of 265 C and mean intraprostatic tissue temperature levels of 50 C with minimal risk of damage to adjacent structures This allows the Targis System to overcome the heat sink effect of the prostatic blood flow resulting in necrosis of a large volume of diseased hyperplastic tissues The CTC Advance Procedure Kit is composed of the following individual components CTC Advance Microwave Catheter Rectal Thermosensing Unit RTU Coolant Bag Each component is a single use disposable designed to be used as a system with the Cont
Download Pdf Manuals
Related Search