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MyoSure® Hysteroscopic Tissue Removal System Frequently Asked Questions



MyoSure Procedure Questions

Can the MyoSure® tissue removal system remove large fibroids?

Yes, the MyoSure XL system is designed to remove a 5cm fibroid in 15 minutes or less of cutting time. It is helpful to thoroughly evaluate the pathology pre-operatively to enable1 pre-surgical patient counseling. SIS or hysteroscopy are recommended. Once a 2500cc of fluid deficit is reached, patient safety dictates that the procedure should be stopped.

Can the MyoSure® device be used to remove a fibroid that is partially protruding into the uterine cavity, (e.g., a Type II myoma)?

Yes. The MyoSure device may be used to resect Type I or II myomas as long as there is enough fibroid protruding into the uterine cavity to allow the device to "engage" the fibroid.2

Can I remove a fundal fibroid?

Yes. For more information about procedural technique, please see our Physician Training Program.

Can the MyoSure® tissue removal device cut into the myometrium?

No. Because the MyoSure tissue removal device has a 3mm deep side cutting window, the device's cutting depth is limited and it will only cut tissue that extends into the uterine cavity.

Why does the MyoSure® tissue removal system use saline as a uterine distension media?

The MyoSure® system removes pathology via mechanical energy vs. electrical energy and therefore can use saline which is a physiologic distension media. Saline or Ringer's Lactate is recommended for the MyoSure procedure because they are physiologic distension media which, according to AAGL fluid management guidelines, have a higher intravasation safety limit (2500cc) than is available for non-electrolyte media such as Glycine (1000cc). It should be noted, however, that the MyoSure procedure is compatible with all distension media. 3

What are the long-term patient outcomes following the MyoSure® procedure?

The MyoSure system is a new tool to perform hysteroscopic myomectomy. For the purpose of reducing bleeding associated with sub-mucosal fibroids, studies suggest that hysteroscopic myomectomy is nearly 96.4% effective in achieving symptom resolution and can be as high as 70% effective for improving fertility rates. In addition, recurrence rates have been reported as low as 10% five years post procedure.

Can I resect a uterine septum or synechiae with the MyoSure® tissue removal system?

The MyoSure tissue removal system is indicated for the removal of intrauterine tissue. Currently, there are no published studies evaluating the use of the MyoSure system to resect a uterine septum or uterine synechiae.

Questions about NovaSure Endometrial Ablation together with MyoSure Tissue Removal

Can a MyoSure® procedure be followed by a NovaSure® procedure?

There is no data on the use of the NovaSure system following a MyoSure procedure. According to the product's labeling, the NovaSure system is contraindicated in a patient with any anatomic condition that could lead to weakening of the myometrium. Use of the NovaSure system would therefore be contraindicated if there was removal of intrauterine pathology with the MyoSure device that resulted in weakening of the myometrium. Please consult the instructions for use for complete indications, contraindications, warnings, and precautions.

MyoSure Practice, Equipment and Reimbursement Questions

Can the MyoSure® tissue removal system truly be used with any hysteroscopy pump?

Yes, however some pumps have more optimal performance. Any pump which does not have the ability to control flow rate should be considered sub-optimal. Sub-optimal pumps may be adequate for smaller pathology less than 3cm, but may present distension or visualization challenges with larger and more complex pathology.

Is the MyoSure® system covered by Insurance? How do I get reimbursed?

There are three main CPT codes associated with the MyoSure system - CPT 58555 for diagnostic hysteroscopy, CPT 58558 for hysteroscopic polypectomy and CPT 58561 for hysteroscopic fibroid removal. All of these CPT codes are reimbursed by Medicare, Medicaid, and commercial insurance companies. As with all CPT codes, rates vary by geography and site-of-service; accounts should confirm exact rates with insurance companies. For more information, please see our Reimbursement Page or review the MyoSure® Coding & Reimbursement Guide.

Can we perform the MyoSure® tissue removal procedure in the office? What type of sedation do we need?

Limited clinical data indicates that MyoSure procedure can be used in conjunction with an oral sedation/cervical block protocol to remove polyps, Type 0 and Type 1 fibroids less than 3 cm in an office setting4. Most patients report that their discomfort during the procedure is similar to that of a PAP test. There is currently no universal reimbursement available for office-based hysteroscopic myomectomy treatments of any kind.

How do I clean the MyoSure scope?

Please review the MyoSure Scope Cleaning Instructions.

How do I order a sterilization tray or hand-held instruments for the MyoSure scope?

Please review the MyoSure Accessory Kit, available to customers in the U.S.


REFERENCES

1. Miller C, Glazerman L, Roy K, Lukes A. Clinical evaluation of a new hysteroscopic morcellator - Retrospective Case Review. Journal of Clinical Medicine 2(3):163-166, July/August 2009.
2. Wallach EE, Vlahos NF. Uterine myomas: an overview of development, clinical features, and management. Obstet Gynecol. 2004 Aug;104(2):393-406.
3. Loffer FD. Removal of large symptomatic intrauterine growths by the hysteroscopic resectoscope. Obstet Gynecol 1990;76:836-840.
4. American Congress of Obstetricians and Gynecologists. Technology assessment no. 7: hysteroscopy. Obstet Gynecol. 2011 Jun;117(6):1486-91.



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