Genesys HTA ProCerva™
Contents
1. During procedure During procedure Internal Anatomy Involved External Anatomy Involved Potential Cause Cervix Patient Anatomy Cervix Poor Cervical Seal B Action Taken Medication Type of Given Intervention Medication Given Prophylactic Antibiotic Gel No additional action taken Medication Given Prophylactic Antibiotics Estrogen Cream Medication Given Silvadene Cream Clinically Significant Change from Initial Assessment Recovering Resolving Resolved without residual effects Resolved without residual effects Resolved without residual effects Vagina Perineum Inadvertent Movement of the Sheath Poor Cervical Seal Other Table 5 Primary Endpoint Burn Rate ITT Evaluable and Incomplete Population for the Final Analysis N 931 ITT Population 95 Cl Evaluable Population 95 Cl Incomplete Population 95 Cl N 992 N 931 N 61 0 4 4 992 0 1 1 0 0 2 2 931 0 0 0 8 3 3 2 61 0 4 11 3 0 1 1 992 0 1 1 931 0 0 0 6 0 0 61 0 0 5 9 Superficial 2nd Degree involve with internal anatomy 0 1 1 992 0 1 1 931 0 0 0 6 0 0 61 0 0 5 9 and external anatomy and require medical or surgical intervention Deep 2nd Degree 0 0 992 0 0 0 4 3rd Degree 0 0 992 0 0 0 4 Clinically Non significant Burns 0 3 3 992 0 1 0 9 Superficial 2nd Degree 0 1 1 992 0 0 0 6 Deep 2nd Degree 0 0 992 02. 0 0 4 3rd Degree 0 0 992 0 0 0 4 Overall Clinically Significant Burns at follow up days 0 1 1 992 gt 21 days Superficial 2nd Degree involve with internal anatomy 0 1 1 992 and external anatomy and require medical or surgical intervention ma O ooa om aaan puma ma rnowaexi Sonon Dooa Including clinically significant burns at procedure and clinically significant burns at gt 21 days upgraded from clinically non significant burns at procedure 95 Cl Incomplete Population 95 Cl N 61 0 0 0 6 0 0 61 0 0 5 9 0 0 0 6 0 0 0 6 0 0 0 6 0 0 931 0 0 0 4 0 0 931 0 0 0 4 0 1 1 931 0 0 0 6 3 3 2 61 0 0 931 0 0 0 4 3 3 2 61 0 1 041 1 933 0 0 61 0 0 5 9 0 0 931 0 0 0 4 0 0 61 0 0 5 9 0 0 931 0 0 0 4 0 0 61 0 0 5 9 0 1 1 931 0 0 61 0 0 61 0 0 5 9 0 0 61 0 0 5 9 0 4 11 3 0 4 11 3 0 0 0 6 0 0 0 6 0 0 5 9 0 0 0 6 0 1 1 931 0 0 0 6 0 0 61 0 0 5 9 0 0 61 0 0 5 9 0 0 61 0 0 5 9 Table 6 Serious Adverse Device Effects MedDRA Outcome ITT Evaluable and Incomplete Population for the Final Analysis N 931 ITT Population 95 Cl Evaluable Population N 992 N 931 Subjects with at least one Serious adverse event with at least one Serious adverse event 0 1 1 992 0 0 0 6 0 1 1 931 Injury poisoning and p
3. Subjects Lost to Follow up at 24 months returned at 36 Months Population with 36 Month Data Available t Subjects were gt 40 years old reasons for hysterectomy were bleeding 1 and pain myoma 1 One subject previously reported as having a hysterectomy returned at 36 months and had not received a hysterectomy Primary Effectiveness Endpoint Success was based on a reduction in excessive uterine bleeding to normal levels or better A success at 12 months post treatment is defined as a reduction in diary score from gt 150 pre treatment to lt 75 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 in Table 3a for the Intent to Treat ITT Population Table 3a Effectiveness Bleeding Rates for the Intent to Treat Population Intent to Treat Population n 276 HTA System RB 89 4 Months post treatment Number of successful n 127 subjects Number of subjects 70 72 42 3 with Amenorrhea Amenorrhea rate 37 39 35 Note Intent to Treat 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 represents a worst case scenario for effectivene
4. bag after treatment as the fluid at this stage may still be hot e Follow hospital procedures for handling contaminated fluids and disposables e Do not attempt to repair or alter any components parts of the Genesys HTA System All repairs and servicing are to be performed only by authorized Boston Scientific service personnel See the Warranty e Patients who have undergone endometrial ablation who are later placed on hormone replacement therapy should have a progestin included in their regimen in order to avoid the increased risk of endometrial adenocarcinoma associated with unopposed estrogen replacement therapy irrespective of whether total amenorrhea has been achieved after ablation e Use Caution when performing the Genesys HTA System procedure on patients with nickel sensitivity as the Genesys HTA ProCerva Procedure Set contains nickel The safety and effectiveness of the Genesys HTA System has not been evaluated in patients e with a large uterine cavity gt 10 5 cm e with a small uterine cavity lt 6 0 cm e with submucous myomas and or polyps e with intramural fibroids gt 4 cm as documented on ultrasonogram thought to be contributing to menorrhagia such as those which distort the uterine cavity e with bicornuate or full septate uterus e undergoing repeat endometrial ablation procedures e g resection ablation or e who are post menopausal ADVERSE EVENTS The first generation HTA S
5. experienced with hysteroscopic Rollerball endometrial ablation Prior to acceptance in the study subjects underwent a series of screening examinations which primarily documented bleeding status and uterine structure Subjects were required to meet a set of entry criteria Key inclusion criteria for the study were e excessive uterine bleeding as documented by the menstrual diary and calculation worksheet defined by Janssen with a minimum score of 150 e endometrial cavity measuring lt 10 5 cm but gt 6 0 cm e age gt 30 years and e previously failed not tolerated or refused medical therapy i e Depo Provera Preparation GnRH analogs oral contraceptives progestins and Danocrine Suppressant Danazol and as reported by the physician Key exclusion criteria for the study were e age gt 50 years e active pelvic inflammatory disease e clotting defects bleeding disorders or anticoagulant treatments e abnormal pap smear that showed evidence of dysplasia e malignant pathology and or simple hyperplasia as documented by endometrial biopsy e history of gynecologic malignancy within the past 5 years e submucous myomas and or polyps e intramural fibroids gt 4 cm as documented on ultrasonogram thought to be contributing to menorrhagia such as those deforming the uterine cavity e congenital uterine anatomical anomaly such as full septate or bicornuate uterus e previous endometrial ablation pr
6. the procedure sheath to avoid inadvertent thermal injury and to provide visibility of the cervix The temperature of the sheath at this location could be up to 65 C Do not rest the procedure sheath on the vaginal speculum during the procedure Leave the vaginal speculum in place throughout the procedure Confirm that the height of the control unit handle is properly adjusted to the height of the patient s uterus to allow proper fluid flow and pressure during the procedure The laser aiming beam can be used as a secondary means to assist with proper height adjustment Ensure that the height of the control unit handle is no higher than the height of the patient s uterus or fluid leakage into the peritoneal cavity and vagina may occur during the procedure Black K AE lt 5 0 Boston Scientific Master Brand DFU Template 8 2677in x 11 6929in A4 90105918AM eDFU MB Genesys HTA ProCerva EN 90990402 01A e Do not grasp the procedure sheath with the tenaculum as doing so may damage the procedure sheath which could result in thermal injury e Throughout the procedure carefully observe the junction of the procedure sheath with the external cervical os to confirm a tight cervical seal and that there is no fluid leakage e Be Aware The fluid loss alarm signals a loss of at least 10 mL of fluid Fluid losses in excess of 10 mL may occur in cases when the alarm is triggered e Use caution when handling the fluid in the drainage
7. Boston Scientific 2014 10 lt EN gt 9 01 0990402 Genesys HTA ProCerva Procedure Set A Refer to the Genesys HTA System Users Manual for complete setup and use B ONLY Caution Federal Law USA restricts this device to sale by or on the order of a physician The physician using the device must be trained in diagnostic hysteroscopy WARNING Contents supplied STERILE using an ethylene oxide EO process Do not use if sterile barrier is damaged If damage is found call your Boston Scientific representative For single use only Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and or lead to device failure which in turn may result in patient injury illness or death Reuse reprocessing or resterilization may also create a risk of contamination of the device and or cause patient infection or cross infection including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient After use dispose of product and packaging in accordance with hospital administrative and or local government policy INTRODUCTION The Genesys HTA ProCerva Procedure Set consists of a disposable procedure sheath a cassette and a drainage bag It is to be used only with the Genesys HTA System Operational Unit WARNING This
8. andle of the drainage bag onto both of the drainage bag hooks B Connect the drain line luer fitting from the cassette to the drainage bag C After the drainage bag is connected press the Engage Cassette button to engage the cassette to the control unit 3 Setup the saline supply bag and confirm tubing clamps are open as follows A Hang a 3L bag of 0 9 Normal Saline from the IV pole hook B Spike the saline bag Note Ensure that the saline bag ports are pulled away from the bag and into a vertical position and that the saline spike has sufficiently penetrated the bag port to facilitate flow C Confirm that the cassette s supply and drain lines are unclamped 4 Peel open the procedure sheath tray Place its contents onto the sterile field and inspect for damage Do not use if the contents are damaged Observing sterile technique connect the procedure sheath inflow and outflow tubing connectors to the matching color coded sheath connections on the cassette male and female luer style Purple Purple and Yellow Yellow Note Prior to attaching the luer fittings from the procedure sheath to the cassette twist the procedure sheath tubing Y turn counterclockwise This may decrease the likelihood of kinked tubing 5 Attach the scope adapter to the procedure sheath and insert the scope as follows A Attach the sterilized scope adapter to the proximal end of the procedure sheath Note Seat the scope adapte
9. assessed again at follow up Post Procedure 1 When prompted by the system withdraw the procedure sheath from the patient N Reattach the sheath cap to the distal tip of the procedure sheath to prevent fluid from spilling Note If the sheath cap has inadvertently been discarded pinch the supply line tubing clamp and the drain line tubing clamp to help contain the fluid Caution Use caution when handling the fluid in the drainage bag after treatment as the fluid at this stage may still be hot Boston Scientific Master Brand DFU Template 8 2677in x 11 6929in A4 90105918AM eDFU MB Genesys HTA ProCerva EN 90990402 01A 3 Clamp and remove the saline bag after the procedure A Pinch the tubing clamp on the supply line B Detach the saline bag from the cassette s supply line tubing C Remove the saline bag and dispose in accordance with hospital procedures Clamp disconnect and cap the drainage bag after the procedure A Pinch the tubing clamp connected to the cassette s drain line ey Disconnect the luer fitting from the inlet tubing oO Connect the tethered luer cap to the inlet tubing on the drainage bag and close to prevent contents from spilling Note If hazardous fluids are spilled during removal clean up in accordance with hospital procedures Black K AE lt oO 0 D Open the drain valve on the drainage bag and discard the contents in accordance with hospital proced
10. ath serves as the fluid conduit between the cassette and the uterine cavity Effluent is collected in the drainage bag DIRECTIONS FOR USE WARNING The following section is a guide to the setup and removal of the procedure set This section is not a guide to system operation Refer to the Genesys HTA System User s Manual for complete setup and use Pre Procedure 1 Examine the procedure set and insert the cassette into the control unit as follows A Examine the Genesys HTA ProCerva Procedure Set package for damage Do not use if the package is opened or damaged B Open the procedure set package and remove the contents C Inspect each tray for damage Do not use if the procedure sheath or cassette trays are open or damaged D Peel open the cassette tray and remove the cassette and drainage bag from the tray and inspect Do not use if the contents are damaged E Facing the cassette slot position the cassette above the cassette slot with the Boston Scientific logo facing away from control unit F Slide the cassette down until it is fully seated in the control unit The top of the cassette should be flush with the top of the control unit and the two blue LED indicators behind the cassette should illuminate indicating that the cassette is properly inserted 2 Hang the drainage bag attach and engage the cassette as follows A Attach the drainage bag to the right side of the control unit by placing the rigid h
11. ays after the procedure and do NOT e Involve both internal anatomy e g vagina cervix and external anatomy e g vulva perineum buttocks and e Require medical or surgical intervention e g a prescription systemic antibiotics debridement skin grafting etc As described in Table 4 four 4 burns were experienced in the study Three 3 were considered non clinically significant and one 1 was deemed clinically significant due to internal and external anatomy involvement as defined per the protocol All of the burns occurred during the procedure none required intervention three 3 resolved without any residual effects and one 1 was recovering resolving at follow up As defined in Table 5 one 1 clinically significant burn was experienced in the study 0 1 meeting the Primary Statistical Hypothesis that the subject rate of clinically significant burns with the Genesys HTA System be no greater that 1 0 The clinically significant burn rate experienced in the study 0 1 was significantly lower p lt 005 than the Primary Statistical Hypothesis Black K AE lt 5 0 Boston Scientific Master Brand DFU Template 8 2677in x 11 6929in A4 90105918AM eDFU MB Genesys HTA ProCerva EN 90990402 01A Table 4 Registry Study Burn Listings N 931 Initial Burn Classification 1st Degree 1st Degree Superficial 2nd Degree Superficial 2nd Degree Onset Timing During procedure During procedure
12. documentis a guide to the setup and removal of the procedure set This document is nota guide to system operation Refer to the Genesys HTA System User s Manual for complete setup and use INTENDED USE INDICATIONS FOR USE The Genesys HTA System is a hysteroscopic thermal ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia excessive uterine bleeding due to benign causes for whom childbearing is complete CONTRAINDICATIONS The system is contraindicated for use in a patient e who is pregnant or wants to be pregnant in the future as pregnancy after ablation can be dangerous to both mother and fetus who has known or suspected endometrial carcinoma or premalignant change of the endometrium such as adenomatous hyperplasia who has active pelvic inflammatory disease or pyosalpinx who has hydrosalpinx in whom a tight cervical seal cannot be established and maintained around the procedure sheath who has any anatomical condition e g history of previous classical cesarean section or transmural myomectomy or pathologic condition e g long term medical therapy that could lead to weakening of the myometrium e who has an intrauterine device in place or who has an active genital or urinary tract infection e g cervicitis endometritis vaginitis cystitis etc at the time of treatment WARNINGS amp CAUTIONS To ensure the user is aware of all potentia
13. e the procedure sheath The first generation HTA System was redesigned to address fluid leakage concerns resulting from the height of the fluid reservoir The Genesys HTA System control unit is mounted on an adjustable height pedestal that facilitates aligning the patient s uterus with the height of the control unit handle A laser aiming beam from the control unit is a secondary means of ensuring proper height of the control unit Study Endpoints The primary effectiveness endpoint was a validated pictorial menstrual blood loss diary scoring system adapted from Janssen CAH Scholten PC et al based on A Simple Visual Assessment Technique to Discriminate Between Menorrhagia and Normal Menstrual Blood Loss Obstetrics amp Gynecology Vol 85 No 6 June 1995 Treatment success was defined as a reduction in menses from a diary score of gt 150 to lt 75 at one year Overall study success was defined as a statistical difference of lt 20 in patient success rates between the HTA System and RB Secondary effectiveness endpoints evaluated were overall percent decreases in diary scores and responses to a quality of life questionnaire Safety endpoints were adverse events associated with each procedure including system related complications time of procedure and type of anesthesia used Study Methods and Patients Studied A randomized 2 1 prospective multi center clinical investigation was conducted at nine sites using investigators
14. ecyclable Package 2014 Boston Scientific Corporation or its affiliates All rights reserved Black K AE lt 5 0 Boston Scientific Master Brand DFU Template 8 2677in x 11 6929in A4 90105918AM eDFU MB Genesys HTA ProCerva EN 90990402 01A
15. ential complications may result to both mother and fetus in the event of a pregnancy Vaginal discharge Is typically experienced during the first few days following ablation and may last as long as a few weeks Generally the discharge will be bloody during the first few days then serosanguinous at one week post treatment and watery thereafter PRETREATMENT PREPARATION OF PATIENT e The endometrium should be in a basal state prior to Genesys HTA System treatment This can be accomplished by timing the menstrual cycle to the early proliferative phase or administering pretreatment drugs such as GnRH agonists prior to performing the endometrial ablation e As with any hysteroscopic procedure the bladder should be empty e The usual vaginal preparation for hysteroscopy should be employed e Itis recommended that a non steroidal anti inflammatory drug NSAID be given at least one hour prior to treatment and continued post operatively as necessary to reduce intra operative and post operative uterine cramping CLINICAL USE CHECKLIST Prior to the use of the Genesys HTA System on a patient the physician should complete the following checklist to better ensure safe and effective use of the system Note that this is not a comprehensive list but an attempt to cover some of the key issues before a physician uses the Genesys HTA System The physician must e along with ancillary personnel thoroughly read and understand all directions fo
16. g Women with patulous cervix included appropriate fluid loss alarms as technical issues when in fact the alarm was not a technical issue with the device but rather how the device is intended to perform The alarm may have been triggered by a clinical use issue but reported as a technical issue and artificially inflating the overall technical issue rate Black K AE lt 5 0 Boston Scientific Master Brand DFU Template 8 2677in x 11 6929in A4 90105918AM eDFU MB Genesys HTA ProCerva EN 90990402 01A PATIENT SELECTION Menorraghia can be caused by a variety of underlying problems including but not limited to endometrial cancer myomas polyps anovulation drugs and dysfunctional uterine bleeding Patients should always be evaluated to determine the cause of their excessive uterine bleeding before any treatment option is initiated PATIENT COUNSELING As with any procedure the physician needs to discuss with the patient the risks benefits and alternatives to endometrial ablation The Genesys HTA System is intended for use only in women who do not desire to bear children because the likelihood of pregnancy Is significantly decreased following this procedure Patients of childbearing capacity should be counseled that endometrial ablation is not a sterilization procedure and should be counseled on the use of an appropriate birth control method Patients with childbearing capacity should be cautioned that serious pot
17. il the post treatment cooling cycle has been completed as confirmed by the display screen as heated fluid may cause thermal injury to the patient e If system cooling is not possible i e power loss do not remove the procedure sheath from the patient until fluid in the uterus has cooled It may take up to 10 minutes to ensure that fluid temperature in the uterus is below 45 C Exercise care when handling the procedure set because the fluid may still be hot Excessive menstrual clotting at the time of treatment may cause the Genesys HTA ProCerva Procedure Set to become clogged This condition may trigger an alert If the condition cannot be resolved the procedure will be discontinued To avoid clogging the fluid lines with blood clots the procedure should not be scheduled during menses Also consideration should be given to pretreatment with drugs such as GnRH agonists prior to performing the endometrial ablation to help induce hypoestrogenic state Do not place the procedure sheath tubing over the patient s leg or in contact with any part of the user s or patient s anatomy as the tubing carries hot fluid and contact could result in thermal injury The temperature of the tubing could be up to 55 C Ensure that the temperature of the fluid in the cassette is below 45 C prior to disconnection of the Genesys HTA ProCerva Procedure Set Do not look directly into the control unit s laser aiming beam Light from the LED may ca
18. ion e Bench and clinical studies have been conducted which demonstrate that the HTA procedure can be safely and effectively performed with nickel titanium tubal micro inserts in place However the HTA procedure should only be performed after the 3 month tubal occlusion confirmation test Technical Warnings e The Genesys HTA ProCerva Procedure Set is provided sterile and is intended for single use only Do not attempt to resterilize or reuse any component of the procedure set e Scope adapters should be reprocessed in accordance with the validated cleaning and sterilization procedure provided in the Genesys HTA System User s Manual Do not reuse any scope adapter that has not been cleaned and sterilized accordingly e Do not use excessive force when attaching the sheath to the scope adapter as such force may damage device components Thermal injuries to patients have been reported in association with cracked or damaged procedure sheaths adapters e Care must be taken with advancement and movement of the procedure sheath to avoid uterine perforation e The physician must maintain control of the procedure sheath i e not hand it off to another individual for the duration of the treatment to avoid compromising the cervical seal A compromise of the cervical seal could result in fluid leakage through the cervix which could result in thermal injury to surrounding tissue e Once heating has begun do not remove the procedure sheath unt
19. l hazards and risks associated with the Genesys HTA System carefully read all general warnings technical warnings and cautions listed below Leakage of heated fluid can cause serious burn or injury to the tissue contacted including tissue in or around the cervix vagina perineum etc Failure to follow instructions or to heed any WARNINGS or CAUTIONS could result in serious patient or user injury General Warnings e Although endometrial ablation with the Genesys HTA System significantly decreases the likelihood of pregnancy it is not a sterilization procedure The patient should be advised of appropriate birth control methods e 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 e Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation may be at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy This can occur as late as 10 years post procedure e DO NOT perform same day HTA procedure and hysteroscopic tubal occlusion sterilization Ablation may cause intrauterine synechiae which can compromise i e prevent the 3 month confirmation test HSG for the tubal occlusion device Women who have inadequate 3 month confirmation tests cannot rely on the tubal occlusion device for contracept
20. led gt 21days post procedure Final Primary Endpoint Findings Study success was based on the subject rate of clinically significant burns being not significantly greater than 1 Clinically significant burns were defined as Deep 2nd degree Burns that e Involve both internal anatomy e g vagina cervix and external anatomy e g vulva perineum buttocks or e Require medical or surgical intervention e g a prescription systemic antibiotics debridement skin grafting etc over the counter treatments e g topical burn treatments or prophylactic medications medications not intended for treatment of the burn but given per the treating physician s standard practice for prophylaxis even if these are prescription medications would not fulfill these criteria and hence their usage alone would not make these clinically significant burns 3rd degree Full Thickness e Any burns that cannot be verified to satisfy the criteria for non clinically significant burns with follow up gt 21 days after the procedure Non Clinically Significant Burns were captured in the study but were not included in the primary endpoint calculation To be considered a non clinically significant burn it must meet the following criteria 1st degree Superficial burns that are verified to be limited to 1st degree burns through follow up gt 21 days after the procedure Superficial 2nd degree Burns that are verified through follow up gt 21 d
21. nd 32 2 12 2 minutes for the HTA System and RB groups respectively Anesthesia was delivered at the discretion of the investigator and attending anesthesiologist General anesthesia was administered to 55 and 76 of the HTA System and RB subjects respectively Paracervical block with IV sedation was administered to 30 and 13 of the HTA System and RB subjects respectively and paracervical without IV sedation was administered to 15 and 9 of the HTA System and RB subjects respectively POST APPROVAL STUDY SUMMARY Study Objective To prospectively collect data on the use of the Genesys HTA System under normal clinical use Primary Endpoint Clinically significant subject burn with the Genesys HTA System Secondary Endpoint Technical complaint with the Genesys HTA System i e disposable and hardware issues Primary Statistical Hypothesis The subject rate of clinically significant burns with the Genesys HTA System is not significantly greater than 1 Study Design and Patients Studied A multi center single arm performance goal prospective registry study with a planned number of 1 325 subjects and up to 100 study sites was conducted using investigators experienced with the HTA System All enrolled subjects were required to meet the approved indications for use of the Genesys HTA System prior to acceptance in the study Potential study subjects meeting any of the labeled Contraindications were excluded from the study To
22. ocedure and e previous classic cesarean section Subjects received one dose of Lupron Pharmaceutical 7 5 mg on Cycle Day 21 2 days Treatment took place on Cycle Day 19 27 after injection After completion of treatment subjects were followed at 2 weeks and 3 6 12 24 and 36 months post treatment Description of Patients Two hundred seventy six subjects were enrolled in the study at a 2 1 ratio of HTA System vs Rollerball respectively Baseline demographic and gynecological variables were statistically equivalent between the two groups with regard to age HTA System 40 7 years RB 40 6 years race body mass index mean baseline diary score HTA System 596 6 RB 585 5 and other criteria Table 2 describes the accountability of subjects throughout the study period Black K AE lt 5 0 Boston Scientific Master Brand DFU Template 8 2677in x 11 6929in A4 90105918AM eDFU MB Genesys HTA ProCerva EN 90990402 01A Table 2 Subject Accountability Subjects not available at 12 month follow up Unrelated death Lost to follow up Hysterectomyt Population with 12 Month Data Available Subjects not available at 24 month follow up Lost to follow up Hysterectomy Repeat ablations Subjects Lost to Follow up at 12 Months returned at 24 Months Population with 24 Month Data Available Subjects not available at 36 month follow up Lost to follow up Hysterectomy Repeat ablations Uterine Artery Embolization
23. ocedure sheath and sheath cap while a second tray contains the cassette and drainage bag DEVICE DESCRIPTION The Genesys HTA ProCerva Procedure Set consists of a procedure sheath with sheath cap cassette and drainage bag Figure 1 Procedure Sheath Cassette Drainage Bag Figure 1 Procedure Set The procedure sheath circulates the saline to and from the uterus during the procedure The procedure sheath contains two lumens one for fluid delivery and one for fluid return a cervical seal assist feature that aids the user in gaining and maintaining a cervical seal and tubing that attaches the procedure sheath to the cassette A sieve tip on the end of the procedure sheath is intended to minimize the occurrence of occlusion due to uterine debris The procedure sheath also includes a tenaculum stabilizer that when engaged allows the physician to hold the procedure sheath and tenaculum with one hand A hysteroscope not supplied is inserted into the procedure sheath to provide visualization during the procedure Various scope adapters sold separately are available to ensure proper connection between the hysteroscope and procedure sheath A sheath cap is included for priming the system The cassette interfaces with the control unit to facilitate heating cooling and distribution of saline throughout the procedure The cassette contains an internal fluid sensor for fluid measurement during the procedure The procedure she
24. r fully onto the procedure sheath There will be resistance due to an O ring on the procedure sheath ee Turn the knurled knob on the scope adapter approximately 2 14 turns to secure the scope adapter to the procedure sheath Note Do not over tighten the scope adapter as doing so may cause damage to the procedure sheath C Carefully guide the distal end of the hysteroscope through the procedure sheath until it stops in the scope adapter and secure appropriately D Attach the sheath cap to the tip of the procedure sheath To prevent leakage ensure that the sheath cap fully covers the sieve tip area and openings of the distal tip 7 Press the Fill System button to advance to System Preparation Procedure Complete the procedure by following the instructions on the control unit display screen and referring to the Genesys HTA System User s Manual WARNING Once heating has begun maintain a stable sheath position and do not remove the procedure sheath until the post treatment cooling cycle has been completed as confirmed by the display screen as heated fluid may cause thermal injury to the patient If heated fluid leaks onto the patient flush the area with cool saline It is important to assess the area in order to determine if a burn is present If a burn is present determine the severity and an appropriate treatment should be made per the standard of care at your facility It is also recommended that the area be
25. r use Indications and Contraindications supplied with the Genesys HTA System including the Genesys HTA System User s Manual and those for compatible accessories to be used with the Genesys HTA System e be trained to perform diagnostic hysteroscopy e be able to verify that the uterine cavity is properly prepared for the ablation procedure and be able to identify the cornu e be able to observe confirm and maintain proper placement of the hysteroscopic tip beyond the internal os and be able to maintain control of the procedure sheath throughout the entire procedure e neither advance nor withdraw the procedure sheath into or out of the uterine cavity once heating has begun until the cooling is complete e be aware of the appropriate sequence of actions to halt resolve and or continue the treatment in the event the Genesys HTA System detects a fluid loss of 10 mL and e be aware that on the day of treatment previously undetected pathology e g submucous myomas may be present in the endometrial cavity which may affect treatment results HOW SUPPLIED Contents supplied STERILE using an ethylene oxide EO process Store in a cool dry dark place Do not use if package is damaged or opened See product labeling for expiration date Do not use product beyond its expiration date The Genesys HTA ProCerva Procedure Set is supplied in a box containing these Directions for Use and two sealed trays One tray contains the pr
26. rocedural complications System 0 1 1 992 0 0 0 6 0 1 1 931 Organ Class Thermal burn Preferred Term 0 1 1 992 Final Secondary Endpoint Findings 0 0 61 0 0 5 9 0 0 61 0 0 5 9 if suitable action had not been taken or intervention had not been e Collected all burn and SADE events made or if circumstances had been less opportune Only one SADE All burns investigated were stopped prior to completion Fourteen 14 of these technical Was reported for the study 0 1 See Table 6 The SADE represents Large sample size 0 0 0 6 0 1 1 931 0 0 0 6 Seventeen 17 procedures involved a technical complaint and complaints were related to fluid leak either a visible fluid leak the one 1 clinically significant burn experienced in the study or an inability to obtain an adequate seal Thirteen 13 of these incomplete procedures were stopped prior to the delivery of heated saline phase Study Strengths and Limitations Limitations Technical malfunction reporting may have been inconsistently Strengths ii 9 assessed by the sites Some sites may have misinterpreted Serious Adverse Device Effects SADEs Per the approved protocol an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event or that might have led to any of these consequences e Prospective multicenter study Real time peri procedural data Active safety reportin
27. spill from the HTA System and onto the perineum e Fluid leakage through fallopian tubes occurred in two subjects when the fluid reservoir was elevated to a height greater than 115 cm 45 inches above the patient s uterus This action increased the internal system pressure and intrauterine pressure 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 first generation HTA System e thermal injury to adjacent tissue including cervix vagina vulva and or perineum e heated saline escaping from the system into the vascular spaces e hemorrhage e perforation of uterus e complications with pregnancy Note Pregnancy following any endometrial ablation procedure is dangerous to both the mother and the fetus e risks associated with hysteroscopy e post ablation tubal sterilization syndrome e infection or sepsis and e complications leading to serious injury or death CLINICAL TRIAL SUMMARY Purpose To evaluate the safety and effectiveness of the first generation HTA System in comparison to hysteroscopic Rollerball RB technique for endometrial ablation in women with menorrhagia due to benign causes for whom childbearing was complete During the treatment cycle and during cooling when the fluid is hot the display screen in the Genesys HTA System cautions the user not to remov
28. ss See Subject Accountability section for complete accounting of all subjects enrolled in the study a Based on diary score b Based on questionnaire response 62 0 31 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 in Table 3b Table 3b Effectiveness Quality of Life QOL Number of subjects who 167 83 responded 1 year QOL score mean SD t baseline 1 year 54 2 13 5 13 0 15 0 53 3 13 5 11 4 15 2 Leisure activities affected baseline 1year Work and activities of daily life affected baseline 1 year Number of subjects who responded 2 years QOL score at 2 years Number of subjects who responded 3 years QOL score at 3 years t The QOL information was obtained from the Ruta QOL questionnaire with a scoring scale range of 2 6 89 5 A higher score is associated with increased menorrhagia e g mild 37 6 moderate 46 7 and severe 50 7 There is no standard deviation noted for 2 years or 3 years In addition 98 of HTA System subjects and 97 of RB subjects reported satisfaction with their treatments at 36 months post treatment Safety Endpoint Adverse event information is described in the Adverse Events Overall mean treatment time was 26 4 12 1 minutes a
29. ss damage or expense directly or indirectly arising from the use of this instrument BSC neither assumes nor authorizes any other person to assume for it any other or additional liability or responsibility in connection with this instrument BSC assumes no liability with respect to instruments reused reprocessed or resterilized and makes no warranties express or implied including but not limited to merchantability or fitness for a particular purpose with respect to such instruments Depo Provera is a registered trademark of Pharmacia amp Upjohn Co LLC Danocrine is a registered trademark of Sanofi Winthrop Inc Lupron is a registered trademark of TAP Pharmaceuticals Inc ARG Argentina Local Contact Para obtener informacion de contacto de Boston Scientific Argentina SA por favor acceda al link www bostonscientific com arg Brazil BRA Local Contact Para informa es de contato da Boston Scientific do Brasil Ltda por favor acesse o link www bostonscientific com bra EU Authorized EC i Representative Boston Scientific Limited Ballybrit Business Park Galway IRELAND Aus Australian Sponsor Address Boston Scientific Australia Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666 Legal Manufacturer Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752 USA USA Customer Service 888 272 1001 Do not use if package is damaged R
30. tal Number of Enrolled Study Sites and Subjects Eighteen 18 sites participated in the study A total of 1 014 subjects were enrolled 992 subjects were in the Intent to Treat ITT population 931 subjects were in the Evaluable Population and 61 subjects were in the Incomplete Population Total enrollment was less than the planned number of 1 325 due an interim analysis using the O Brien Fleming stopping rule This rule followed the group sequential analysis decision rules for efficacy where enrollment could cease early if the rate of clinically significant burns for the registry was low and significantly less than the 1 0 stated in the protocol The rate of clinically significant burns for the 820 Evaluable subjects at the time of the first group sequential decision rule 0 1 1 820 was Statistically significantly lower p lt 0 005 than the hypothesis rate of 1 0 This result enabled the study to not require any additional subject enrollment and it ceased at 1 014 subjects Study Visits and Follow up Requirements Study visits were all in person and were limited to investigators reviewing the eligibility requirements with the subject obtaining Informed Consent and performing the procedure all could be performed same day Any additional study visits were related to follow up only and as scheduled in the protocol only required for subjects that experienced a burn Follow up visits for subjects that experienced a burn were schedu
31. to and following treatment with the HTA System was usually sufficient to manage cramping e Nausea and vomiting were generally attributed to certain types of general anesthesia e Asymptomatic alterations in cervical tissue ranged from erythema to shallow ulcerations and were resolved without treatment within 30 days following the ablation procedure e Patients with endometritis responded to a course of antibiotics e Hematometra was resolved with insertion of a uterine sound e Thermal injury to extremity involved a second degree burn in 1 HTA System subject This burn occurred following prolonged exposure of skin lower leg to the heated tubing of the HTA System during treatment The subject was treated with topical antibiotics and dressing changes The system was modified after the occurrence of this event to reduce this risk of injury e Other events which occurred in no greater than 3 of subjects treated with the HTA System included diarrhea fever headaches abdominal distension and post ablation tubal sterilization syndrome During the development of the first generation HTA System prior to the multi center randomized clinical study described above a prototype was evaluated in a feasibility study in which the following adverse events were reported e Fluid leakage into the vagina occurred in one subject when the procedure sheath was withdrawn from the subject during the treatment cycle This action caused the fluid to
32. ures E Safely dispose of the drainage bag and contents in accordance with hospital procedures 5 Once prompted by the system pull the cassette straight up to remove Ensure the cassette is held upright and handle carefully to prevent contamination from residual fluids Note At the end of the procedure the disposable procedure set components may contain approximately 270 mL of fluid 6 Remove the hysteroscope and scope adapter from the procedure sheath and route both for sterilization according to hospital procedures 7 Dispose of the cassette and procedure sheath according to hospital safe disposal procedures WARRANTY Boston Scientific Corporation BSC warrants that reasonable care has been used in the design and manufacture of this instrument This warranty is in lieu of and excludes all other warranties not expressly set forth herein whether express or implied by operation of law or otherwise including but not limited to any implied warranties of merchantability or fitness for a particular purpose Handling storage cleaning and sterilization of this instrument as well as other factors relating to the patient diagnosis treatment surgical procedures and other matters beyond BSC s control directly affect the instrument and the results obtained from its use BSC s obligation under this warranty is limited to the repair or replacement of this instrument and BSC shall not be liable for any incidental or consequential lo
33. use retinal damage Do not over dilate the cervix Cautions Endometrial ablation procedures using the Genesys HTA System should be performed only by physicians trained in diagnostic hysteroscopy procedures Follow all Genesys HTA System instructions to reduce the possibility of compromised safety malfunction and or injury to the patient and or the user To avoid the risk of electric shock ensure that the selected electrical supply outlet has a proper ground connection and complies with the information listed on the label located on the rear of the control unit To reduce the risk of explosion do not operate the Genesys HTA System in the presence of flammable anesthetics or a flammable gas mixture with air oxygen or nitrous oxide Never use the Genesys HTA System with equipment that has not been safety tested for excessive leakage current Exercise care when handling liquids around electrical equipment Do not attempt to operate the Genesys HTA System if liquid has spilled onto the unit The Genesys HTA System must be used only with the procedure sheath provided in the Genesys HTA ProCerva Procedure Set Use of any other hysteroscopic procedure sheath sets will lead to compromised safety for the patient and user Do not hang more than three liters of saline from the hook on the IV pole Confirm that the vaginal speculum is an adequate size width and length to assure full separation of vaginal and vulvar tissue away from
34. ystem was evaluated in a randomized prospective multi center clinical trial comparing the HTA System to Rollerball RB as the control arm Adverse events for both study arms were reported from the time of procedure through the 1 year follow up study period Tables 1a 1b and 1c present these results Table 1a Adverse Events within 24 Hours Post Procedure HTA System RB Group n 85 Adverse Events Group n 184 Uterine cramping Vomiting Abdominal pain Urinary tract infection 5 3 2 2 2 1 2 2 Endometritis 2 1 1 1 Table 1b Adverse Events at 2 Weeks Post Procedure HTA System RB Group n 85 Adverse Events Group arom nw n 184 Transient change in 19 10 0 0 appearance of the cervical 17 9 2 2 Laceration epithelium Vomiting Urinary tract infection UTI Abdominal pain Endometritis Thermal injury to extremity Vaginal infection Cervical laceration Table 1c Adverse Events at 3 6 and 12 Months Post Procedure HTA System Group RB Group Nasa TC Urinary tract 1 1 1 1 infection Note This table reports individual events Multiple events may have occurred in the same patient Additional information related to some of the adverse events reported during the multi center clinical trial is provided below e Peri operative uterine cramping typically lasted a few days following ablation Use of non steroidal anti inflammatory drugs NSAIDs prior
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