15491 1/29/07 2:04 pm page f hta .potential physician benefits of performing the hta® procedure

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  • HTA System In-Office Global Endometrial Ablation

    15491 1/29/07 2:04 PM Page F

  • POTENTIAL PHYSICIAN BENEFITS OF PERFORMING THEHTA PROCEDURE IN AN OFFICE SETTING

    Time savings and flexibility

    - Schedule on days and times convenient for the physician

    Favorable Reimbursement

    - 2007 Medicare rate of $2,185 with private reimbursementpotentially up to $3,600

    Practice Marketing Opportunity

    - Potentially increase profitable practice revenue with or without adding new patients

    Synergy with other office based procedures

    - Set-up and procedure regimen conducive to performingin-office procedures such as hysteroscopy and sterilization

    Potential Physician and Patient Benefits

    Important Please Note: Reimbursement information provided by Boston ScientificCorporation (BSC) is gathered from third-party sources and is presented forillustrative purposes only. This information does not constitute reimbursement orlegal advice, and BSC makes no representation or warranty regarding this informationor its completeness, accuracy or timeliness. Laws, regulations and payer policiesconcerning reimbursement are complex and change frequently, and service providersare responsible for all decisions relating to coding and reimbursement submissions.Accordingly, BSC strongly recommends that you consult with your payers,reimbursement specialist and/or legal counsel regarding coding, coverage andreimbursement matters.

    15491 1/29/07 2:04 PM Page B

  • POTENTIAL PATIENT BENEFITS OF PERFORMING THE HTA

    PROCEDURE IN AN OFFICE SETTING

    Less anxiety

    - More comfortable setting than ASC or Hospital

    Overall shorter time from admit to discharge

    - Less pre-procedure fluid and food intake restriction ifanesthesia is not required

    May reduce risk/effects of general anesthesia

    - Potential for quicker recovery time if general anesthesia is not required

    Less out-of-pocket expense for some private insurance plans

    - Office co-pay fee vs. surgery deductible ($$)

    Potential Physician and Patient Benefits

    15491 1/29/07 3:01 PM Page F

  • CLINICAL REVIEW OF OFFICE EXPERIENCE AND OUTCOMES WITH THE HTA SYSTEM

    Physician Experience In-office

    Farrugia M, Hussain S. Hysteroscopic endometrial ablation using the HTASystem in an outpatient hysteroscopy clinic: feasibility and acceptability. Journal of Minimally Invasive Gynecology. 2006;13(3):178-182

    40 of 40 patients treated under paracervical block with oral sedation

    Glasser MH. Perioperative Pain Management and Why it Works. Presented at AAGL. 11-2006

    285 HTA System procedures performed under paracervical block with oral sedation over 5 years without any reports of procedures discontinued because of pain

    Interview with Dr. Mark Glasser, January 18, 2007, PDM #90321474.

    54 Patients treated under paracervical block with oral sedation, including 22 patients with irregular shaped cavities

    Phillips R. Practical In-office Experience with the HTA System. PosterPresentation at AAGL. 11-2006

    55 patient survey respondents reported an average peak pain score of 3.60 on an analog pain scale of 1-10 during the ablation procedure

    HTA System Clinical Review

    50 10

    3.6

    15491 1/29/07 3:01 PM Page B

  • HTA

    System

    Clinical Review

    Clinical Outcomes

    Donovan A. Review of 419 Cases of Endometrial Ablation with the Use of theHTA System for the Treatment of Menorrhagia. Podium Presentation at 34thAnnual Meeting of AAGL. 11-2005

    6 to 48 month follow-up of 419 patients from single private practice setting. 77% reported outcomes of amenorrhea or no protection necessary.

    Goldrath MH. Evaluation of HydroThermAblator and Rollerball EndometrialAblation for Menorrhagia 3 years after Treatment. Journal of the AmericanAssociation of Gynecologic Laparoscopists. 2003;10(4):505-511

    53% reported amenorrhea (per protocol 72/136) at 3 years from original FDA PMA clinical trial

    0

    20%

    40%

    60%

    80%

    100%

    120%

    46%

    93%

    53%

    98%

    24 Months 36 Months

    Amenorrhea Patient Satisfaction

    15491 1/29/07 2:03 PM Page F

  • SUMMARY OF TECHNIQUE SPOTLIGHT

    Authored by

    Summary of Anesthesia Technique Spotlight

    Mark Glasser, MDKaiser Health San Rafael, CADepartment of Gynecology

    Robert Nadelberg, MDNewton-Wellesley Hospital, Newton MADepartment of Anesthesia

    Authors Recommendation for Pre and Post-Procedure Pain Management

    1. Ibuprofen 800mg. (Meclomen 100mg , Cataflam 50mg) - taken night before 2. Diazepam 10mg - taken 1-2 hours prior to procedure3. Vicodin 2 tabs - taken 1-2 hours prior to procedure4. Toradol 30 mg + Atropine 0.4mg IM - taken 30 minutes pre-procedure5. Atarax Sedative 25 mg (2 tabs) or Anzemet Tablets 100 mg for post op

    nausea prevention (give to patient to take at home if necessary)* Use discretion in prescribing combinations of analgesics and sedatives. The

    above are recommendations and should be tailored to the individual patient.

    Safe anesthesia and successful procedure outcomes are dependent upon:

    Patient Selection Careful Technique Clinical Vigilance2 31

    Patient Selection

    To minimize the potential for adverse anesthetic outcomes, any electivemedical procedure should be limited to patients with no significant co-morbid conditions who fall into the classification of the American Societyof Anesthesiologists Physical Status 1 or 2. In addition, patient selectioncriteria should also include the patients tolerance for pain and ordiscomfort, level of anxiety, and preference for the type of setting theprocedure will be performed in such as a physicians office vs. a hospital/outpatient operating room.

    1

    This Technique Spotlight was sponsored by Boston Scientific. The opinions expressed in this Technique Spotlight are those of theauthors alone. Boston Scientific makes no representations or warranties as to the accuracy or completeness of the information herein.

    15491 1/29/07 2:03 PM Page B

  • Summ

    ary of Anesthesia Technique Spotlight

    2

    3

    Careful Technique

    If choosing to treat patient under local anesthesia, an effective Para Cervical Block will facilitate the introduction of cervical instruments such as the HTA Systems procedure sheath.

    Para Cervical Block Technique

    Clinical Vigilance

    Observe patient carefully for progression of sedation beyond anxiolysis. The most common cause of complications in selecting local anesthesia for any procedure relates to the progression of sedation to a level deeper than anticipated and consequent problems resulting in hypoxia andcardiovascular instability.

    The definitions of levels of sedation are as follows:

    **Reflex withdrawal from a painful stimulus is NOT considered a purposeful response.

    This Technique Spotlight was sponsored by Boston Scientific. The opinions expressed in this Technique Spotlight are those of theauthors alone. Boston Scientific makes no representations or warranties as to the accuracy or completeness of the information herein.

    1. 15 cc 1%, Carbocaine

    Anesthetic, Polocaine

    Anesthetic at 8 o'clock and 4 o'clock (alternatively the use of 2% chloroprocaine [2% Nesacaine Anesthetic - MPF2%] or 1% Xylocaine [Lidocaine])

    2. Give 5 cc intracervical 1cm deep and 10 cc Para Cervical submucosally to raise weal

    3. 5-10 cc submucosally between uterosacrals

    4. Monitor patients BP/Pulse using a patient vital signs monitoring system

    Total Dose = 37cc (370 mg)(Mepivicaine)

    Recommended Maximum dose = 400 mg (Mepivicaine)

    Maximum dose given withoutadverse effects = 550 mg*

    Injecting at 6 oclock is key in providing an optimal block

    15491 1/29/07 2:03 PM Page F

  • TECHNOLOGY MATRIX1

    Source: Competitive SS&E documents1 HTA Presentation MVU5450

    Technology Comparison

    HTA System ThermaChoice

    SystemHer Option

    SystemNovaSure

    System

    Vision

    Direct visualization

    No direct visualization

    No direct visualization

    No direct visualization

    Visual confirmationof sheath positionbefore activation

    Possible activationin false passage

    Possible activationin false passage

    Possible activationin false passage

    - -Requires

    concurrent ultrasound

    -

    Anatomy

    Cavity 6-10.5cm Cavity 6-10cm Cavity 6-10cm Cavity 6-10cm

    Includes irregularshapes and intramural

    fibroids 4cm

    Includes intramuralfibroids 2cm

    Includes intramuralfibroids 2cm

    Includes intramuralfibroids 2cm

    Pressure &Manipulation

    Low pressure and noprobe movement is

    designed to reduce discomfort

    High pressure Probe movement Probe movementElectro stimulation

    15491 1/29/07 2:03 PM Page B

  • Technology Comparison

    GEA TECHNOLOGY REPORTED OUTCOMES2

    Note: No direct comparison can be made due to differences in manufacturers clinical study protocol1 Per Protocol Patients (72/136)2 Carter JF, Endometrial Ablation: More Choices, More Options. The Female Patient. 2005;30(12):35-403 This Data has not been published, however it has been presented during a podium presentation at the 2005AAGL annual meeting

    HTA System ThermaChoice

    SystemHer Option

    SystemNovaSure

    System3

    PostproceduralInterval 3y 3y 1y 3y

    Amenorrhea 53%1 15% 22% 44%

    SatisfactoryReduction in

    Bleeding41% 53% 45% 43%

    Success(Amenorrhea +Reduction in

    Bleeding)

    94% 68% 67% 87%

    15491 1/29/07 2:03 PM Page F

  • HYPOTHETICAL HTA SYSTEM IN-OFFICE PROFITAB