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

HTA System In-Office Global Endometrial Ablation

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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.

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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

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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

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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

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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.

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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

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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

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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%

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HYPOTHETICAL HTA SYSTEM IN-OFFICE PROFITAB