A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)

Inclusion Criteria:

- Healthy female between 18 and 55 years of age

- Subject must be able to understand, read and sign the study specific informed consent
forms after the nature of the study has been fully explained to her

- Subject is a pre-menopausal or peri-menopausal female, either nulliparous or parous

- Subject is experiencing AUB as confirmed by a symptom raw score of 23 or a calculated
symptom score of 44.0 or higher on the Uterine Fibroid Scale and Health Related
Quality of Life (UFS-QOL)

- Subject is indicated for myomectomy or polypectomy for benign appearing pathology,
based on a hysteroscopic exam and measured by saline infused sonogram assessment
within 30 days of the planned index procedure

- Subject exhibits intrauterine polyps and/or submucous myomas which, in the opinion of
the treating physician, are compatible with office-based treatment (e.g. 15 minutes
or less of cutting time) using the MyoSure device and meet at least one of the
following criteria:

- One or more polyps, with at least one of the polyps ≥ 1.5 cm and ≤ 3.0 cm diameter
and having broad based attachment to the uterine wall.

- Up to two Type 0 or Type 1 myomas with at least one of the myomas being ≥ 1.5 cm and
none of the myomas being 3.0 cm diameter

- If the first myoma is 3.0 cm, the second myoma must be ≤ 2.0 cm

- Fundal myomas must be Type 0

- Polyps plus up to two Type 0 or Type I myomas with at least one of the myomas being ≥
1.5cm and ≤ 3.0 cm

- The subject demonstrates a negative pregnancy test within 48 hours prior to the
planned index procedure

- The subject must document a score of 5 or lower on the Pap Smear and Blood Draw
scales of the Pain Tolerance Survey

Exclusion Criteria:

- Subject has known or suspected cancer, including breast, endometrial, and ovarian

- Contraindication and/or allergy to local anesthetic, or oral medications specified in
the treatment protocol

- The subject has a history of chronic narcotic use

- Previous uterine artery embolization or other uterine artery occlusion procedure
(Doppler or laparoscopic)

- Subject has blood borne pathogens-HIV, hepatitis B, CJD, etc.

- Subject has an IUD at the time of the procedure. A subject may be enrolled in the
study if the IUD is removed prior to the treatment procedure

- Subject is taking an anticoagulant or antiplatelet medication other than low dose
aspirin

- Active pelvic inflammatory disease or pelvic/vaginal infection

- Subject has a known or suspected coagulopathy or bleeding disorder

- Subject has a history of unmanaged endocrine disease

- Subject has current or past, acute or chronic psychiatric disorder which, in the
opinion of the Investigator, may preclude proper evaluation and follow-up

- Subject has a history of auto-immune, inflammatory, or connective tissue disease

- Subject has a history of disease which increases the risk for fluid overload (i.e.
significant cardiac, hepatic, or renal dysfunction)

- Uncontrolled hypertension lasting two years or more

- Use of any experimental drug or device within 30 days prior to the screening visit

- The subject has a terminal illness that may prevent the completion of any follow-up
assessments

- Any employee or relative of an employee of the Sponsor company or any Investigator
site employee or relative of employees working on the study

- Subject has other co-morbid condition(s) that, in the opinion of the Investigator,
could limit the subject's ability to participate in the study or impact the
scientific integrity of the study

- Subject has one of the following:

- Type II submucosal myoma

- Type O or Type I submucosal myoma > 3.0 cm

- Fundal Type I myoma

- Highly vascularized myoma as determined by SIS or hysteroscopic examination