Her Option Instructions for Use
Contents
1. adverse events in the cryoablation group Tables 1a 1c summarize the adverse events for the 272 patients treated in this study Table 1a Adverse Events During Procedure and within 24 hours Post Procedure Adverse Event Cryoablation REA n 186 n 86 Uterine cramping 15 8 4 5 Other abdominal or pelvic pain cramping Cervical vaginal laceration O 0 1 1 Cryo perforation occurred during sounding prior to treatment REA perforation occurred during treatment Table 1b Adverse Events at 2 week Post Procedure Adverse Event Cryoablation REA n 186 n 86 5 3 0 0 7 4 8 9 Table 1c Adverse Events at 3 6 and 12 months Post Procedure Adverse Event Cryoablation Group REA Group rae n 86 Uterine cramping 5 6 Other abdominal or pelvic pain cramping 1 16 19 Vaginal infection 1 1 Hot flashes Urinary tract infection Nausea vomiting 1 oom 1 1 Below is a more detailed description of the Adverse Events reported above e Pelvic Pain Cramping Peri operative cramping typically lasted a few hours and rarely continued beyond the first day following ablation Some of the mild cramping was reported as resolved without medication The use of non steroidal anti inflammatory drugs NSAID s was reported to typically manage the cramping and pain e Nausea and Vomiting Nausea and vomiting was managed with medication e Bladder Infection Vaginal Infection The infections were m2. that the system is operating properly a PreCool cycle or a test freeze cycle should be conducted in air with every new disposable probe prior to placing probe in patient If the disposable probe is switched during a procedure for any reason a test freeze cycle in air should be initiated by pressing the minus button immediately Verify that the temperature reading on the console reaches 50 C e Always monitor the temperature on the console display and verify that it is reading the temperature as expected i e temperature is decreasing during cooling cycles and increasing during heating cycles e Spark generation is possible DO NOT use the system in an oxygen rich environment e Do not bend the Cryoprobe or the Disposable Probe e The Flexline is delicate and consists of four separate tubes each carrying fluids Avoid sharp bending of the Flexline or pulling on the Flexline as a means of moving the Her Option Office Cryoablation Therapy Console e If the power is interrupted during one of the freeze cycles or the display temperature fails to achieve 20 C use room temperature normal saline to accelerate the heating process and allow removal of the Probe e Do not attempt to disassemble the Her Option Office Cryoablation Therapy Console Cryoprobe or sterile Disposable Probe e DO NOT allow the ventilation holes on the Console to become obstructed damage may occur e The Probe tip may become adherent to the tissue during freezing Allo
3. 0 REA 82 1 Year CRYO 157 REA 73 2 Years CRYO 74 REA 25 3 Years CRYO 76 REA 22 Percentage of subjects very extremely satisfied 1 Year CRYO 157 REA 73 2 Years CRYO 90 REA 36 3 Years CRYO 103 REA 38 Percentage of subjects who would recommend therapy to a friend 1 Year CRYO 157 REA 73 2 Years CRYO 89 REA 36 3 Years CRYO 102 REA 37 Responses include only subjects experiencing menstruation or symptoms Those not menstruating or experiencing symptoms did not complete this section of the questionnaire Responses were not recorded for all subjects Safety Endpoint Adverse event information is described in the Adverse Events section of this manual Anesthesia and Dilation Anesthesia was delivered at the discretion of the investigator and attending anesthesiologist General anesthesia was administered to 92 79 86 of the REA patients and 46 85 186 of the cryoablation patients Of the cryoablation group 39 72 186 of the patients received a paracervical block with conscious sedation as compared to only 1 1 86 of the REA group There are data specific to the degree of dilation available on 164 cryoablation patients and 76 REA patients Of these patients twenty one 11 of the cryoablation patients did not receive any dilation whereas all 100 REA patients received some degree of dilation This difference is statistically significant with a p value of 0 0003 Clinical Study Observatio
4. 4 Hysterectomy Repeat Ablation Subjects not available at 24 Month Follow up Lost to follow up Hysterectomy a ES OE Population with 24 Month Data Available YOO 7 S G 18 0 3 Subjects not available at 36 Month Follow up Lost to follow up 0 0 Hysterectomy 2 Subjects Lost to Follow up at 24 months returned at 36 Months 15 3 18 Population with 36 Month Data Available Results Primary Effectiveness Endpoint Patient success was based on a reduction in excessive uterine bleeding to normal levels or better A success at 12 months post procedure is defined as a reduction in diary scores from gt 150 pre treatment to lt 75 Amenorrhea is defined as a score of 0 Success at 24 and 36 months is defined as Amenorrhea no bleeding Hypomenorrhea light bleeding or Eumenorrhea normal menstrual bleeding as reported by subject via questionnaire Results at 12 24 and 36 months post treatment are presented below for the Intent to Treat ITT Population Table 2 Effectiveness Bleeding Rates for the Intent to Treat Populationt Intent to Treat Population N 279 Cryoablation n 193 Months post treatment Number of successful subjects 47 20 20 Intent to Treatment ITT population represents all subjects enrolled in the study including those considered as failures because they were not available for follow up did not receive treatment and or received partial treatment Therefore the ITT group re
5. anaged with oral antibiotics e Other Events Other Adverse Events reported which occurred in no greater than 1 of the patients treated with Her Option include severe bleeding more than two weeks following the procedure difficulty recovering from anesthesia and pregnancy 1 patient Other Adverse Events As with all endometrial ablation procedures serious injury or death can occur The following adverse events could occur or have been reported in association with the use of the Her Option Cryoablation Therapy System Endometritis Difficulty with defecation or micturation Hematometra Thermal injury to adjacent tissue Hemorrhage Post ablation tubal sterilization syndrome Perforation of Uterus Complications with pregnancy Note Pregnancy following any endometrial ablation procedure is dangerous to both the mother and the fetus e Uterine necrosis e Infection or sepsis e Complications leading to serious injury or death Clinical Study Purpose The use of cryoablation in the treatment of menorrhagia from benign causes in pre menopausal women was compared to REA to evaluate safety and effectiveness Study Endpoints The primary effectiveness measure was a validated menstrual diary scoring system developed by Higham JM O Brien PMS Shaw RW Assessment of menstrual blood loss using a pictorial chart Br J Obstet Gynaecol 1990 97 734 9 Patient success was defined as a reduction in menstrual flow at 1 year to a diary sco
6. ary to visualize and monitor the growth of the CryoZone with ultrasound The freeze cycle should be stopped if the leading edge of the CryoZone approaches within 2mm the serosal surface Precautions Endometrial ablation procedures using the Her Option Office Cryoablation Therapy System should be performed only by physicians trained in gynecologic ultrasound lt has been reported in the literature that patients with a severely anteverted retroflexed or laterally displaced uterus are at greater risk of uterine wall perforation during any intrauterine manipulation A false passage can occur during any procedure in which the uterus is instrumented especially in cases of severely anteverted retroflexed or laterally displaced uterus Use caution to ensure that the device is properly positioned in the uterine cavity The Her Option Office Cryoablation Therapy System is a sealed system Tampering with the Console or Cryoprobe may result in loss of gas and loss of effectiveness Clean and disinfect the stainless steel Cryoprobe according to instructions under Sterilization and Cleaning in the User s Manual Do not autoclave Do not immerse cryoprobe in liquids Do not use the Disposable Probe if there is any evidence of tampering or damage to the sterile package It is very important that the PreCool cycle be conducted using the Disposable Probe that will be used for the treatment Test probes should NOT be used for PreCool cycle e To ensure
7. awing process of initial CryoZone Confirm appropriate placement by injecting Saline in the uterine cavity and identifying the flow of saline using ultrasound guidance In addition ultrasound visualization can be used to verify that the placement of the probe is out of the first CryoZone by visualizing the tip while sliding the probe in and out for approximately 1 cm The second freeze should last for only 6 minutes or less if the CryoZone leading edge approaches 2mm of the serosal surface Note The Probe should only be withdrawn from the CryoZone when the registered tip temperature is above 20 C For Immediate Technical Support Call U S STERILIZATION METHOD GAMMA STERILE CE 0086 for Life American Medical Systems Inc 10700 Bren Road West Minnetonka MN 55343 USA U S Toll Free 800 328 3881 Phone 952 930 6000 Fax 952 930 6157 www AmericanMedicalSystems com All rights reserved Printed in USA Order Number 23300141 05 07 800 328 3881 Outside U S 01 952 930 6000 11
8. ner option office cryoablation therapy Caution Federal USA law prohibits this device to sale by or on the order of a physician trained in gynecologic ultrasound Package Insert f Package insert for USA use only Notice d utilisation pour utilisation exclusive aux Etats Unis Packungsbeilage gilt nur in den USA ll foglietto illustrativo della confezione pu essere usato solo negli USA Prospecto adjunto solo para utilizarse en EUA Device Description and Principle of Operation The Her Option Office Cryoablation Therapy System is an office based cryoablative treatment which uses a gas cooled cryoprobe to ablate the endometrial lining of the uterus Its operation is based on the Joule Thomson principle in which pressurized gas is expanded through a small orifice to produce cooling The coolant or gas used in the system is a proprietary blend of commonly used coolants which are non toxic non corrosive non flammable and non CFC The system is intended to destroy tissue during ablation procedures by the application of extreme cold at the distal tip of the Cryoprobe A 20 C temperature is lethal to tissue The ice front advances through the uterine tissue creating a CryoZone rather than expanding within the endometrial cavity The Her Option Office Cryoablation Therapy System includes a Console a Cryoprobe and a Disposable Probe The Cryoprobe with Disposable Probe attached is referred to as the Probe A compressor housed in the Co
9. ngitis or cystitis e A patient with active pelvic inflammatory disease PID e A patient with an intrauterine device IUD currently in place e A patient with any anatomic or pathologic condition e g chronic immunosuppressive therapy in which weakness of the myometrium could exist such as history of previous classical cesarean sections or transmural myomectomy Warnings Failure to follow any instructions or to heed any warnings or precautions could result in serious patient injury Office Based As is the case with office based procedures such as endometrial biopsy loop electrosurgical excision procedure LEEP hysteroscopy and endometrial ablation physicians that perform HerOption Office Cryoablation Therapy should follow these general recommendations Vasovagal effects can occur with any manipulation of the cervix Office personnel should be trained in airway management with advanced cardiac life support Prepare an emergency kit with appropriate pharmacological agents to assist in managing emergency situations be prepared to check blood pressure and provide hemostasis for cervical lacerations Know your local anesthetic s maximum dose To avoid the risk of overdose draw out the maximum dosage Overdose symptoms include dizziness lightheadedness tinnitus depression and systole In case of severe reaction be prepared to administer appropriate pharmacological agents General Although endometrial ablation with the He
10. ns Hysterectomy There were a total of 28 patients 16 Cryoablation 12 REA who had hysterectomies within 3 years following endometrial ablation Table 4 Summary of Reasons for Hysterectomy within 3 years Reason for Hysterectomy Cryoablation REA n 193 n 86 Menorraghia Abnormal Uterine Bleeding Unreported Unknown Ovarian Cyst Ovarian Cancer Severe PMS 2 Ten Hysterectomies were in patients lt 40 years 6 Cryoablation 4 REA 18 hysterectomies were in patients gt 40 years 10 Cryoablation 8 REA based on age at the time of the cryoablation therapy a a a 1 Patient Selection Menorrhagia can be caused by a variety of underlying problems including but not limited to endometrial cancer hormone imbalance anovulation drugs myomas and polyps Patients should be thoroughly evaluated to determine the cause of the menorrhagia prior to any treatment being initiated Patient Selection for Office Based Procedures Patients with the following conditions may not be appropriate candidates for office based procedures Patients who have uncontrolled anxiety pain or moderate systemic diseases such as hypertension arrhythmias arteriosclerotic vascular disease severe obstructive lung disease Patients who have a difficult anatomy which impedes ultrasound visualization Patient Information Patients should be counseled regarding the risks benefits and alternatives prior to the performance of this proced
11. nsole is fully charged with coolant and is semi hermetically sealed prior to shipping to ensure zero leakage Activation of the System freeze cycle causes gas to exit the compressor and flow to the Probe where it expands to a low pressure across a small diameter orifice at the tip of the Probe As a result a rapid temperature drop occurs This temperature drop is transferred to the tissue contacting tip of the Disposable Probe causing freezing Gas then returns to the compressor and is recirculated Deactivation of the freeze cycle stops gas flow to the Probe ending cooling The sterile Her Option Office Cryoablation Therapy Disposable Probe is sold separately Indications The Her Option Office Cryoablation Therapy System is a closed cycle cryoablative device intended to ablate the endometrial lining of the uterus in pre menopausal women with menorrhagia or excessive bleeding due to benign causes for whom childbearing is complete Contraindications The device is contraindicated for use in e A patient who is pregnant or who desires to become pregnant in the future Pregnancies following ablation can be dangerous for both mother and fetus e A patient with a known or suspected endometrial carcinoma uterine cancer or premalignant change of the endometrium such as unresolved adenomatous hyperplasia e A patient with an active genital or urinary tract infection at the time of the procedure e g cervicitis vaginitis endometritis salpi
12. ocking tabs are fully engaged into the Cryoprobe handle A PreCool Cycle must be performed immediately prior to use The PreCool Cycle will last approximately 2 5 minutes and the heating portion ends when the heater automatically warms up to 37 C Begin the first freeze within 60 minutes of the PreCool Cycle otherwise the PreCool Cycle may have to be repeated The user will be prompted if a Precool is necessary The Precool Cycle should be performed with the Probe outside the patient s uterus Caution It is very important that the PreCool cycle be conducted with the Disposable Probe that will be used for the treatment Test probes should not be used for PreCool cycle You may need to dilate the cervix to 6mm For optimal image when using ultrasound guidance in positioning the Probe the bladder should be full to ensure adequate ultrasound imaging 5 10cc of saline injected into the uterus eliminates air pockets and will ensure good thermal contact between the Probe and the tissue The first freeze cycle should be terminated by depressing the Heat button after 4 minutes or earlier if ultrasound imaging indicates that the CryoZone leading edge approaches 2mm of the serosal surface of the uterus At the completion of the heat cycle inject 5 10cc of saline and reposition towards the opposite lateral cornu Verify correct placement with ultrasound If probe resistance is encountered during the second placement inject warm saline to expedite the th
13. presents a worse case scenario for effectiveness See Subject Accountability section for complete accounting of all subjects enrolled in the study Based on diary score Based on questionnaire response Number of subjects with Amenorrhea Amenorrhea rate 130 60 Study success rate Secondary Effectiveness Endpoint Quality of Life QOL information was obtained by comparing QOL scores obtained via questionnaire at pre treatment and at 12 24 and 36 months post treatment These scores were compared and the results are presented below Effectiveness Quality of Life Quality of Life QOL data was obtained at one year post operatively using the SF 36 Health Survey as well as a version of the validated Dartmouth COOP assessment tool Because there are no QOL questions pertaining to menorrhagia approval from the Dartmouth Committee was granted to use the same style of questions and format them according to the study design Parameters included SF 36 PMS symptoms and menstrual pain indices A telephone survey was also conducted at 2 and 3 years post operatively Table 3 summarizes QOL responses to the survey Table 3 Quality of Life QoL Scores Out to 3 Years Post Treatment Effect on QoL 1 Not at all 5 Extremely Pre operatively CRYO 180 REA 82 1 Year CRYO 157 REA 73 2 Years CRYO 72 REA 25 3 Years CRYO 75 REA 22 Percentage of subjects reported time lost from work other activities Pre operatively CRYO 18
14. r Option Office Cryoablation Therapy System significantly decreases the likelihood of pregnancy it is not a sterilization procedure The patient should be advised of appropriate birth control methods Endometrial ablation does not eliminate the potential for endometrial hyperplasia or adenocarcinoma of the endometrium and may mask the physician s ability to detect or make a diagnosis of such pathology Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy This can occur as late as 10 years post procedure Technical Endometrial ablation procedures using the Her Option Office Cryoablation Therapy System should be performed only by medical professionals who have experience in performing procedures within the uterine cavity such as IUD insertion or dilation and curettage D amp C and who have adequate training and familiarity with use of the Her Option System The sterile Her Option Office Disposable Probe is for single use only Do not attempt to re sterilize or reuse Use caution not to perforate the uterine wall when sounding the uterus or inserting the Cryoprobe Ifa perforation is present the procedure should be terminated immediately There is the potential for thermal injury to adjacent organs if the CryoZone extends beyond the serosal surface of the uterus therefore it is necess
15. re of lt 75 Study success was defined as a statistical difference of less than 20 in patient success rates between Cryoablation and REA Secondary endpoints included responses from a quality of life questionnaire Safety 4 evaluation was based on the adverse events reported during the study including device related complications The type of anesthesia required to complete the procedure was also recorded Methods A randomized 2 1 prospective study was conducted at 10 clinical sites which included 275 patients diagnosed with menorrhagia Study subjects were required to meet the following key inclusion exclusion criteria Inclusion criteria e Premenopausal female between 30 and 50 years of age in good general health e Documented history of excessive uterine bleeding and a completed pictorial blood assessment chart PBAC of gt 150 for at least one menstrual cycle Previously failed or refused traditional medical therapy D amp C and Depo Provera Uterine sound measurement lt 10 cm Uterine volumetric measurement lt 300 cc e Patient does not desire to maintain fertility Exclusion criteria Clotting defects or bleeding disorders Poor general health Patient below age 30 or above age 50 Active pelvic inflammatory disease Abnormal pap smear within the previous year unless appropriately evaluated History of gynecologic malignancy within the past 5 years Intramural myomas greater than 2 cm diameter Intrauterine polyps Pedunculated fibroid
16. rence Levy Barbara A Isaacson Keith Office based treatment of abnormal uterine bleeding OBG Management September 2003 Physician Preparation Physician preparation for procedure is dictated by the site of service i e office setting ASC operating room etc and local practice standard Site Preparation Patient is placed in dorsal lithotomy position Physician prepares perineum vagina and cervix with antiseptic solution per local practice Physician uses sterile drape exposing perineum only Physician conducts pelvic examination to determine size shape and position of cervix and uterus Physician sounds cervix and uterus Physician employs speculum and or retractors and sufficient illumination so as to provide adequate visualization of the cervix oe NS Directions For Use The following directions provide some of the salient points for the use of Her Option Office Cryoablation Therapy System Please read the User s Manual before operating the system The use of the Her Option Office Cryoablation Therapy System requires two people a non sterile Assistant and a sterile gloved Physician The Console display provides information that will help guide you during the procedure pay attention to the screen display The sterile Disposable Probe should always be handled using sterile technique To attach the Disposable Probe to the Cryoprobe use a slow steady motion and gently push the Disposable Probe until the l
17. s Septate uterus Previous endometrial ablation procedure or other uterine surgery in which thinning of the uterine musculature occurs e Malignant pathology or hyperplasia within the previous six months as documented by endometrial biopsy e Pregnancy e Women who desire to maintain fertility Menstrual diary scores were collected pre treatment and at 3 6 and 12 months post treatment Patients were given Lupron 3 75mg 28 days prior to the cryoablation therapy Patient Population A total of 279 patients were enrolled in this study in a 2 1 ratio of Cryoablation to Rollerball respectively Baseline characteristics between Cryoablation and REA patients were compared and found to be statistically equivalent with regard to age body mass index gravidity parity full term deliveries previous Cesarean section previous D amp C previous tubal ligation presence of fibroids or myomas cavity sounding length severe menstrual pain and cramping severe PMS symptoms medical therapy for menorrhagia hematocrit and FSH One variable pretreatment PBAC diary scores demonstrated moderate statistical significance p lt 0 05 Median pretreatment PBAC scores were higher in the group treated with cryoablation Subject Accountability Co SO Cryoablation _ REA Intentto Treat Population TT Subject Withdrawals _ _ _ _ Jo o A S 0 y A Complications Incomplete Treatment 6 Z 4A 7 183 Subjects not available at 12 Month Follow up Lost to follow up 1
18. trained and familiar with the following procedures and techniques e intrauterine gynecological procedures recognizing the tip of the probe in the uterus and the CryoZone as it advances toward the serosa placing the tip of the probe in the uterine cornu confirming via ultrasound maintenance of the proper placement of the probe tip and cryoablation of the cervix The physician as well as adjunctive personnel should review and be familiar with the Her Option Office Cryoablation Therapy System training material Users Manual training video Clinical Use protocol Power Source Specification Voltages 100 120 220 240 Vams Frequency 50 60 Hz Rating 1200 VA PROBE CRYOPROBE WITH A DISPOSABLE PROBE Heat Button Amber Light Kevoad Freeze Button Green Light ue gt T VAENE TTA ae a Handle Probe a serai 5 5 mm x 22 cm n Locking Tabs ip w Thermocouple Injection Port Irrigation Port g and Heater Average CryoZone Dimensions Six Minute Freeze Two Minute Four Minute Freeze Freeze 5 4 cm 5 8 cm 5 0 cm 2 0 cm 2 6 cm 3 0 cm The CryoZone dimensions illustrated above were obtained during in vitro testing in media that simulates tissue Please note that the illustrations above represent the growth of the CryoZone over a period of time Ultrasound provides visualization of the CryoZone and the proximity of the leading edge to the serosal surface of the uterus ETR 04060 Article Refe
19. ure This counseling should include the need for post procedure contraception where indicated This procedure is not a sterilization procedure and subsequent pregnancies may be dangerous for the mother and fetus Vaginal discharge is possible following the procedure This may last from a few days to a few weeks Any unusual or foul smelling draining should be reported to the physician immediately Pre Op Work Up The Pre op work up should include History and complete physical examination including pelvic exam Negative PAP smear and endometrial biopsy to rule out cervical or endometrial malignancy and pre malignant changes to the uterus Sonography hysteroscopy hystero salpingography or any other indicated diagnostic test or procedure that might uncover a possible cause for menorrhagia within six months of performing the Her Option procedure Pre Treatment Preparation of Patient lt is recommended that the lining of the uterine cavity be thinned prior to Her Option Office Cryoablation Therapy Thinning can be accomplished by administering a GnRH agonist 21 28 days prior to the procedure or performing suction curretage immediately prior to the cryoablation procedure A non steroidal anti inflammatory drug NSAID may be given to the patient one hour prior to the treatment and continued post operatively as needed Clinical Use Checklist Prior to using Her Option Office Cryoablation Therapy for the first time physicians should be
20. w adequate time during the heat cycle for tissue to warm before attempting to remove the Probe approximately 2 minutes or when the temperature achieves 20 C Do not attempt to remove Probe from tissue if there is significant resistance If an error condition exists use room temperature saline rather than the heat cycle to loosen the probe from the tissue e Patients who have undergone endometrial ablation and are later placed on hormone replacement therapy should have progestin included in their medication regimen in order to avoid the increased risk of endometrial adenocarcinoma associated with unopposed estrogen replacement therapy e The safety and effectiveness of Her Option Office Cryoablation Therapy System for ablation of the endometrial lining of the uterus has not been fully evaluated in patients with a uterus greater than 300cc in volume or a uterine sound greater than 10 cm with a uterine sound less than 4 cm who have undergone a previous endometrial ablation procedure with intramural myomas gt 2 cm in diameter intrauterine polyps or pedunculated fibroids with a septate uterus or who are post menopausal VVVVVV Adverse Events The Her Option Office Cryoablation Therapy System was evaluated in a randomized prospective multi center clinical study comparing the Her Option Cryoablation Therapy to a control arm of rollerball endometrial ablation REA There were no reported incidents of serious device related
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