Cavaterm System. o Disposable silicone balloon catheter / adjustable balloon length

Transcription

1 Cavaterm

2 Cavaterm System o Disposable silicone balloon catheter / adjustable balloon length o Battery operated control unit o Heating element at temp of 80 C o Glycine filled and oscillating o 10 minute treatment not suitable for treatment under local anesthesia o Recently purchased by a French company trying to re-launch in parts of Europe, including the UK.

3 NovoSure Bipolar Radio Frequency Ablation (Hologic) Impedance Controlled Electrocoagulation Disposable intra-uterine measuring device Radiofrequency Generator with suction capability Disposable ablation instrument with bipolar electrode NovoSure Bipolar Radio Frequency Ablation ** Current market leader because of fast treatment time, high amenorrhea rates, ability to treat under local anesthesia and large aggressive sales force! **

4 NovoSure Bipolar Radio Frequency Ablation (Hologic) Technique Three dimensional bipolar mesh is expanded until it is in contact with the endometrium Suction is then applied to the endometrial cavity drawing it closer to the mesh Continuous suction throughout the procedure ensures contact with endometrium and removal of vaporized tissue

5 Generator applies up to 180 watts of bipolar power while steam and moisture are removed by suction System will shut down when complete desiccation (calculated at 50 ohms of resistance) has occurred Average treatment time 90 seconds

6 NovoSure Bipolar Radio Frequency Ablation (Hologic) o Advantages - no pretreatment - short treatment time (1-2 min) - high Amenorrhea rates - perforation detection test (?) o Disadvantages - cervical dilatation 9 mm - limitation of cavity size and shape (Does not treat large cavities well) - pre-op measuring of uterine cavity - painful to seat the device into the cornua - De Novo Pain reported higher than Balloon Ablation Techniques o Patient Satisfaction 93%

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9 Training: Part 5 Thermablate Endometrial Ablation System

10 SIMPLE SAFE EFFECTIVE WELL TOLERATED

11 THERMABLATE-EAS Disposable silicone balloon Re-circulating glycerine solution < 100 C Interface Balloon and Endometrium Fully automated pressure and temperature 2 minute 6 second treatment

12 About the Procedure Patient Eligibility o Normal endometrial biopsy (within past 6 months) and pap smear o Normal size and shape intrauterine cavity (8-12 cm sounding external os to fundus) o Fertility is not required any longer o Easy, non painful cervical/uterine access during office biopsy or hysteroscopy (for outpatient ablation)

13 About the Procedure Prior to the Treatment o Pre treatment of endometrium is desirable (oral contraceptives, Nuva Ring, Mirena IUD, suction curettage) o Hysterosopy prior to balloon insertion is recommended to ensure uterus has not been perforated during dilatation/sounding or curettage (if performed) o Dilate gently to 7 mm

14 About the Procedure - The Treatment User inserts the 6mm, heat shielded, soft-tipped catheter into the uterine cavity to the predetermined depth Initiates treatment with a simple finger trigger TCU s pneumatic system transfers fluid through the catheter to inflate the silicone balloon to a set pressure of 220 mmhg System inflates and deflates the balloon 3 times (30 secs, 30 secs, 60 secs) to maintain consistent balloon surface contact with uterine cavity, creating uniform temperature of fluid within the balloon Total treatment time is 2 minutes and 6 seconds

15 Features and Benefits Lightweight and Portable Easy to transport, set up and disassemble Easy to operate with automatic time, temperature and pressure control Fast, Accurate Display LCD screen provides information on temperature, pressure and treatment time remaining Well tolerated Well suited for use under local anesthesia; most patients discharged 1 2 hours post procedure

16 Competitive Comparators Ease of use Efficacy Safety Pain Tolerance Cost Effectiveness

17 Ease of Use Thermablate is only fully automated global ablation device Shortest treatment time* Portable

18 SIMPLE EXPERIENCE THE FREEDOM & FLEXIBILITY OF THERMABLATE EAS o Thermablate EAS is a fully automated, portable medical device used to carry out global endometrial ablation for the treatment of menorrhagia o Easy to operate and requires minimal training for the physician. The only fully automated ablation system on the market o Total treatment time of 2 minutes and 6 seconds.

19 EFFICACY All global technologies provide 80-85% patient satisfaction and similar rates of avoidance of further surgical intervention Selection of technology should be based on ease of use, patient tolerance, and cost effectiveness Dr. Nick Leyland speaking at RCOG Sept. 2007

20 EFFICACY Definition from the Oxford dictionary: The ability to produce a desired or intended result What is the desired result of an endometrial ablation procedure?

21 Efficacy in Endometrial Ablation Common measurements of efficacy of ablation: Reduction in bleeding amenorrhea ( no bleeding) hypomenorrhea (minimal bleeding, spotting) eurmenorrhea ( return to a normal period) Improvement in dysmenorrhea - pain associated with menstruation Patient satisfaction - was the patient satisfied with outcome? (subjective depending on expectations, would the patient recommend treatment to a friend?) Improvement in quality of life*

22 Reduction in Bleeding- Amenorrhea Some gynecologists focus on amenorrhea (absence of bleeding) as the primary measure of success in an ablation treatment Studies have shown that the majority of women do not seek amenorrhea* The primary goals of an endometrial ablation are: 1. to improve the quality of life of the woman so she might return to a normal social life 2. to avoid a hysterectomy (if amenorrhea is the desired outcome, only a hysterectomy will guarantee it. Women who choose ablation do not want a hysterectomy!!!)

23 Reduction In Bleeding Actual Rates In FDA clinical trials for ablation devices, success is defined as reducing the monthly blood flow to a score of less than 75 on the PBLAC chart (pictoral blood loss chart) The following summary demonstrates that the various ablation technologies all perform relatively equally in reducing menstrual flow: Thermachoice ( hot liquid filled balloon) Her Option ( cryo energy / Freezing) HTA (free flowing warmed saline via hysterscope) Novasure (bipolar radiofrequency) Microsoulis (microwave) Rollerball* ( hysteroscopic coagualtion)

24 GLOBAL TECHNOLOGIES FDA Clinical Study Results at 1 year Device Device Success* Rollerball Success * Thermachoice 80% 84% Her Option 67% 73% HTA 68% 76% Novasure 77% 74% Microsulis 87% 83% Overall 76% 78% *Success rate based on PBLAC score <75

25 How Does The Patient Define Efficacy? Return to a more normal life- at home, work and play Retention of uterus the patient has chosen an ablation procedure as they do not want a hysterectomy

26 Amenorrhea and Patient Satisfaction Rates vs. Quality of Life Improvement Poor correlation was seen between amenorrhea rates and improved quality of life. These two variables should not be seen as interchangeable Amenorrhea is easily measured, but is not necessarily a reflection of patients opinion of the procedure, and indeed many women express significant dissatisfaction when amenorrhea occurs in association with persistent or de novo pain Quality of Life Should Be Considered the Primary Outcome When Measuring Success Of Endometrial Ablation J Am Assoc Gynecol Laporosc 2003, J.Abbott, J.Hawe, R.Gary.

27 Reduction in Bleeding and Patient Satisfaction Rates Most clinical studies on ablation success, both randomized (RCT) and retrospective studies, focus on reduction in bleeding (often amenorrhea rates), and on patient satisfaction rates (can be very subjective) as indicators of success. Pivotal studies with long term follow up demonstrate that at 5 and 10 years there is no significant long term difference between the two most popular technologies: Thermal balloon ablation Bipolar radiofrequency

28 By: Paul Smith (Research Fellow) Supervised by: T Justin Clark of Birmingham Women s Hospital

29 Objectives Compare Thermal Balloon Ablation to Bipolar Radiofrequency Ablation at 5 years follow-up for: Effectiveness - amenorrhoea rates, resolution of menorrhagia, decrease in dysmenorrhoea Health related quality of life Further surgery/hysterectomy rates

30 Conclusions and Discussion Office endometrial ablation using both TBA and BRFA is feasible and effective This trial provided no strong evidence of a difference in efficacy at 5yrs Kleijn J, Engels R, Bourdrez P, Mol B, Bongers M. Five-year follow-up of a randomised controlled trial comparing NovaSure and Thermachoice endometrial ablation. BJOG 2008;115: Daniels J, Middleton L, Champaneria R, Khan K, Cooper K, Mol B, Bhattacharya S, Second generation endometrial ablation techniques for heavy menstrual bleeding: network meta-analysis. BMJ 2012 Apr 23;344

31 Ten-year follow-up of a randomised controlled trial comparing bipolar endometrial ablation with balloon ablation for heavy menstrual bleeding MC Herman,a JPM Penninx,a BW Mol,a,b MY Bongers Objective: Previously, we have reported that, at both 12 months and 5 years after treatment, bipolar endometrial ablation is superior to balloon ablation in the treatment of heavy menstrual bleeding. In this article, we evaluate the results at 10 years after these interventions. Conclusion: Ten years after treatment, the superiority of bipolar ablation over balloon ablation in the treatment of heavy menstrual bleeding was no longer evident. Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands b Department of Obstetrics and Gynaecology, AMC Amsterdam, the Netherlands, Accepted 11 February Published Online 21 March 2013.

32 A Retrospective Review of Patient Outcomes Comparing Novasure, Thermablate, MEA and the Mirena Intrauterine System Menstrual loss improved in 95% of thethermablate group, 90% of the Novasure group, 72% of the MEA group and 88% Mirena group. Conclusion: Thermablate patients reported the greatest improvements in menorrhagia (95%) and dysmenorrhea (76%).

33 If Reduction in Bleeding and Patient Satisfaction Rates are Similar for TBA and BRFA, what differentiates the two? Pain during the procedure Avoidance of New Pain (De Novo Pelvic Pain) Re-intervention Rates -specifically hysterectomy rates

34 Pain During the Procedure Pain Tolerance Thermblate EAS offers physicians an innovative treatment option that is proven to be as effective, yet significantly less painful than competitor global ablation products, both during and after treatment

35 Thermablate: the Nottingham Study, 2008 Prasad P & Powell MC. JMIG 2008;15:476-9 Intra-operative: 42% reported mild/moderate at 1 & 2 min Post-operative Pain: 33% at 1 min, 57% at 30 min 81% were happy with intra-operative analgesia None requested procedure be stopped 88% were satisfied with outpatient procedure 93% would have procedure again min time spent in clinic 100% returned to work within 2 days

36 Thermal Balloon Endometrial Ablation System Office Based Global Endometrial Ablation: Feasibility & Outcome for 3 modalities Nick Leyland, M.D.St. Joseph s Health Centre, University of Toronto, Toronto, Canada Thermblate EAS offers physicians an innovative treatment option that is proven to be as effective, yet significantly less painful than competitor global ablation products, both during and after treatment Patient pain tolerances were measured using vas (visual analog pain scale management) which showed lower pain levels both intra and post operatively for thermablate eas when compared with the novasure system. Pain Scale (0 = No Pain to 10 = Worst Pain)

37 New Pelvic Pain Post Procedure: De Novo Pain Success measured as IMPROVED QUALITY OF LIFE

38 Incidence of de Novo Pelvic Pain After Radiofrequency or Thermal Balloon Global Endometrial Ablation Therapy Results: De novo pelvic pain occurred overall in 20% of RF and 7% TB. The incidence of pain was greater after RF than after TB at each time endpoint Conclusions: In closing, as more focus is being placed on improved quality of life measures rather than just menstrual patterns postablation, de novo pelvic pain occurrence and severity after two common GEA technologies have been documented. The incidence as well as its associated severity varies by mode of therapy (RF > TB). The possibility of de novo pelvic pain after treatment should be reviewed with patients pre-procedure. Chapa H, Antonetti A, Sandate J, Bakker K, Silver L. Incidence of de Novo Pelvic Pain After Radiofrequency of Thermabl Balloon Global Endometrial Ablation Therapy. J Gynecol Surg 2010; 27.

39 Re-Intervention Rates and Avoidance of Hysterectomy As stated previously the primary goals of endometrial ablation are to: Improve quality of life for the woman avoid a hysterectomy

40 Endometrial Ablation: Where Have We Been? Where are We Going? Success & patient satisfaction seem to be enduring in well-selected patients Repeat surgery, usually hysterectomy is performed in 25% - 40% by 5 years after ablation!

41 Probability of Hysterectomy After Endometrial Ablation Mindyn K. Longionotti, MD, Gavin F. Jacobson, MD, Yun-Yi Hung, PhD, and Lee A. Learman, MD, PhD (Obstet Gynecol 2008;112: ) 3681 ablations by 344 physicians at 30 Kaiser Perm Northern CA from Jan 99- Dec 2004 Hysterectomy: 25-30% Addit treat: 4% <45 yr, Hyst 2.1X

42 Subsequent Intervention Rates following Thermablate and Novasure Endometrial Ablations Objective: To determine intervention rates following either Thermablate or Novasure Ablations Design: A retrospective comparison over 5 years Setting: The Gynaecology Department at the Nottingham CIRCLE Treatment Centre Nottingham University NHS Trust between Jan 2008 and November 2013 Patients: 133 and 175 women treated with Novasure and Thermablate, respectively. Interventions: Women attending the out patient department presented with symptoms of heavy menstrual bleeding. They were offered an outpatient thermablate ablation or a local or general anaesthetic Novasure. The records were reviewed to ascertain additional interventions that were subsequently performed.

43 Subsequent Intervention Rates following Thermablate and Novasure Endometrial Ablations No Subsequent Intervention Conservative Intervention Hysterectomy Thermablate NovaSure

44 Subsequent Intervention Rates following Thermablate and Novasure Endometrial Ablations Conclusions: Thermablate patients had a higher rate of conservative intervention but a lower rate of hysterectomy compared with the Novasure group ( p=0.35), based on a 95% confidence interval. This may well be because the Novasure procedure destroys the uterine cavity more than the Thermablate, so fewer interventions such as a resection are possible. Therefore with persistent symptoms of bleeding or pain after a Novasure ablation, a hysterectomy may be the only available option. This has implications for everyday practice when making a decision as to what initial treatment is appropriate, as well as cost implications for the National Health Service.

45 Conclusions All endometrial ablation devices provide similar results in overall reduction in bleeding and patient satisfaction rates Thermal Balloon Ablation provides an advantage in : 1. less pain during the procedure under local anesthesia 2. significantly lower rate of de novo pelvic pain 3. more options for conservative re-intervention (TCRE, Mirena insertion) 4. significantly lower rate of hysterectomy

46 Conclusions Thermal Balloon Ablation Provides the Patient with: 1. Greater opportunity for Improvement in Quality of Life 2. Greater opportunity to avoid hysterectomy

47 Safety Adverse Events have occurred with all endometrial ablation devices, the most serious being thermal damage to non-targeted tissue No serious adverse events with Thermablate when used in protocol

48 Safety A false passage can occur during any procedure in which the uterus is instrumented, especially in cases of severe anteverted retroflexed or a laterally displaced uterus. The only completely safe method, is to adhere to the MHRA Guidelines: HYSTEROSCOPY IMMEDIATELY PRIOR TO INITIATING TREATMENT

49 Medical Device Alert Action update Ref: MDA/2010/006 Issued: 18 January 2010 at 11:30 Device Devices used for endometrial ablation. All makes and models. Problem Action The MHRA continues to receive reports of uterine wall injury, wall perforation, or the creation of a false passage following use of endometrial ablation devices. In some cases resection of damaged tissue has been required.

50 MHRA Guidance Document 2011 (UK) Clinicians are recommended to: employ hysteroscopy prior to the insertion of the ablation device to establish the condition of the uterus OR employ ultrasound to ensure correct uterine placement of the ablation device. If the device uses a balloon, this should remain inflated during the ultrasound scan.

51 MHRA Recommendations: Summary Correct patient selection Proper Training of Gynecologist Adherence to Manufacturers recommendations

52 Thermablate Instructions for Use Reflects the MHRA recommendations to include: - Correct patient selection - Hysteroscopy immediately prior to insertion of balloon/catheter to check for perforation or - Confirmation of correct balloon placement with trans-abdominal ultrasound prior to initiation of treatment

53 Conclusion: > 90% serious adverse events occur when device used in protocol

54 SAFE GYNECARE THERMACHOICE* III Uterine Balloon Therapy With Fluid Circulation THERMABLATE EAS Thermal Balloon Endometrial Ablation System Method of Ablation Thermal Thermal Operating Termperature 87 C 173 Operating Pressure 180mmHg 220mmHg Average Procedure Time (duration between patient prep and catheter removal) 24.7 minutes < 10 minutes Total Treatment Time 8 minutes 2 minutes 6 seconds Pre-Heating of Fluid IFU Reflects recommendations of MHRA Occurrence of thermal bowel Injury and/or transmural thermal injury when used according to manufacturers labeled instructions After the start button is pressed, controller activates the heat to achieve treatment temperature of 87 C (188 F) within 4 minutes. NO YES >85% of such events reported to the FDA occurred when physician followed manufacturers labeled instructions Occurs prior to insertion of catheter does not pose risk of electrical burn to patient or increase total procedure time. Not dependent on size of uterine cavity. YES NO such events have occurred when physician has been in compliance with manufacturers labeled instructions

55 SAFE NOVASURE - Impedence Controlled Endometrial Ablation System Thermablate EAS Thermal Balloon Endometrial Ablation System Method of Ablation Radio Frequency Energy Thermal Energy Procedure Time 90 seconds 2 minutes 6 seconds Uterine Cavity Limitations IFU reflects recommendations of MHRA Occurrence of thermal bowel injury and/or transmural thermal injury when used according to manufacturers labeled instructions Cannot treat patients with cavity length less than 4cm and/or patients with cavisty width less than 2.5cm. The safety and effectiveness of the NovaSure system has not been fully evaluated in patients with a uterine sounds measurement greater than 10cm NO YES - >90% of such events reported to the FDA occurred when physician followed manufacturers labeled instructions Safely and effectively treats uterine cavities with sounding measurements of 8 12cm, regardless of cervical canal or width of cavity YES NO such events have occurred when physician has been in compliance with manufacturers labeled instructions

56 Thermablate EAS No adverse event has been reported with the Thermablate Endometrial Ablation system when the Treatment Protocol and Instructions for Use have been followed The Thermablate system is the only believe ablation device that informs users of the necessity of employing hysteroscopy just prior to device insertion, as per the MHRA guidance document

57 Prevention of Perforation During initial office assessment for AUB 1. Must do Pelvic exam to determine POSITION of uterus 2. Endometrial Biopsy to determine: a) Ease of biopsy catheter insertion b) Depth of uterine cavity (cm markings) c) Pain tolerance d) Endometrial histopathology

58 Prevention of Perforation: Preselect the Patients Prior to Thermablate commitment to determine normality of uterine cavity: Sonography (TVS, Saline/Gel Infusion) and/or Hysteroscopy

59 Prevention of Perforation Prepare the Cervix & Patient Post- Thermablate commitment & before treatment 1. Cervical Ripening evening before with: Misoprostol 400mcg vaginal suppository or oral 2. Prescribe/provide adequate Analgesia

60 Cervical Ripening o Consider when cervical stenosis is known or anticipated (nulliparous, LEEP procedure, GnRH-a treated women) o Misoprostol µg oral or vaginal 12 hr pre-op o Laminaria tent > 4 hr pre-op o Intracervical injection of vasopressors or xylocaine

61 Cervical Ripening: Misoprostol Vag vs. Oral (RCT) o 86 premenopausal women o Misoprostol 400 mcg hr o Mean cervical diameter: 7.3mm vs. 6.0mm o Time of dilation: 49 sec vs. 99 sec o Uterine perforation 0 vs. 5.1% Batukan, et al. Fertil Steril 2008;89:966-73

62 Prevention of Perforation: Prepare Yourself Pre-Thermablate Treatment after adequate analgesia (Local, IV sedation, General) 1. Pelvic exam to reconfirm POSITION 2. Apply tenaculum to straighten cervix/uterine canal 3. Sound uterus. Should be similar to office sound 4. Dilate cervix gradually to 7mm (should be easy) 5. Hysteroscopy to exclude false passage / perforation

63 Thermablate Treatment: Prevention / Early Recognition 1. Hysteroscopy to know where you re going 2. Insert Thermablate (easy) sounding depth 3. Activate Thermablate treatment 4. Ultrasound is desirable if available 5. Post-treatment hysteroscopy to know where you ve been

64 Temperatures within Canister & during Thermablate Treatment: MDMI bench data submitted to FDA o ~ C (~ F) within Canister prior to treatment o ~ C (~ F) within intrauterine balloon at start of treatment o < C (< F) at Balloon/Endometrial interface o No steam is generated in contradistinction to Novasure treatment

65 Cost Effectiveness True cost effectiveness for global ablation is that it may be performed in the outpatient setting under local anesthesia, thus avoiding the resource intense operating theatre

66 40% Less Staff in Ambulatory! Outpatient vs. Theatre Outpatient Consultant (Mid-Level) Nurse (Band 6 Nurse) Nurse (Band 6 Nurse) Auxiliary Nurse Theatre Consultant Assistant Anaesthetist ODP - Nurse - Nurse - Runner Total: 4 Staff per session Total Cost: 300 per hour Total: 7 Staff per session Total Cost: 1,200 per hour

67 Hospital becomes money generating

68 Business Case Competitive Advantages Continue providing Safe High Quality Patient Care and Evolving Services e.g. earlier diagnosis of cancer Follow Best Practice Free up Theatre time for more complex surgical sessions Increase Profitability Impact of Not Funding Project Loss of income from inefficiencies Loss of service to other (willing) qualified providers Potential Loss of credibility vis-à-vis other local & national Foundation Trusts.

69 SWOT Analysis: Thermablate in the UK - Best suited for Ambulatory setting - Fast treatment time - Low peri-operative pain scores - Small, portable, compact - Fully automated & hassle free - Low re-intervention & hysterectomy - High Efficacy & Patient Satisfaction Strengths Weaknesses - Less clinical data vs. competitors - Less ability to bundle products - Lower Amenorrhea rates than Novasure - Cavity integrity test - J&J not investing in gynaecology, no plans for product development or improvement - Novasure less flexible on price UK very price sensitive market currently - Growing and fast moving trend towards Ambulatory Gynaecology Opportunities Threats - Hologic: very aggressive sales force, false claims about efficacy, reducing size of probe - J&J able to bundle products, reduce tenders, win tenders - Some new competitors arriving on the market uncertainty

70 Competitive Comparators Ease of use Efficacy Safety Patient Tolerance Cost Effectiveness

71 Thermablate EAS is a simple, safe and effective minimally invasive procedure that is optimal for the outpatient setting o Easiest to use o Safest to use o High patient satisfaction rates o Best Tolerated by Patients o Most cost effective best suited to outpatient setting

72 SIMPLE SAFE EFFECTIVE WELL TOLERATED