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MyoSure® Procedure Clinical Literature: Proven Outcomes

Hysteroscopic myomectomy is the standard of care for treating symptomatic submucosal fibroids and polyps. Overall efficacy for reducing heavy periods caused by submucosal fibroids is greater than 90 percent with a less than 2 percent complication rate and a recurrence rate of less than 20 percent at five years. 1-4

Given the limitations of current treatment options, there is a continued need on the part of OBGYN interventionalists and their patients for a device that is fast, easy to learn, safe to use and capable of immediately removing resected fibroid and polyp tissue from the uterine cavity to preserve visualization of the operative field.

The MyoSure® tissue removal system has been clinically evaluated to assess cutting efficiency, tissue removal capability of the MyoSure device. Total fluid volumes and fluid deficit during the MyoSure procedure were also assessed. Download the clinical evaluation by Dr. Greenberg et al.

This study demonstrated that the MyoSure hysteroscopic tissue removal device is an efficient treatment option for the removal of submucous myomas and polyps from the uterine cavity. The mean treatment time for resection of target pathology for each type of case was as follows:

TABLE 1 - TREATMENT OUTCOMES VS.PATHOLOGY TYPE & SIZE

Pathology Type Size (cm)
(Mean; range)
Treatment Time (min:sec)
(Mean; range)
% Tissue
Removed
Wt. Tissue Removed (g)
(Mean; range)
Polyps 1.2; 3-3.0 00:54; 00:03-03.07 100% 2.0; 0.2-6.0
Type 0 Myomas 2.2;1.0-3.0 04:19;00:38-13:10 99% 20.5;1.8-59.5
Type I Myomas 2.9;7-5.0 08:11;00:14-24:19 96% 20.5; 1.8-59.5
Type II Myomas 4.9; 1.0-15.0 07:47; 03:07 - 15:00 66% 12.5; 1.8-43.7


No patient treated with the MyoSure device experienced an acute-onset adverse event either intra-operatively or during post-procedure recovery. Total fluid volumes and fluid deficit varied depending on the type of pathology and duration of the procedure as presented in the following charts. The fluid deficit ranged from 30 ml for a polyp (0:42 sec resection time) to 600 ml for a 4 cm Type II fibroid (11:42 min:sec resection time). The equivalent total fluid volume for these procedures was 1.9L and 17.5L, respectively.

To learn more, watch the Clinical Case Review, Presented by J. Greenberg MD at AAGL 2009. Additional clinical articles are below:

Clinical Evaluation of a New Hysteroscopic Morcellator - Retrospective Case Review

Objective: The objective of this study was to clinically assess the cutting efficiency and safety of a new hysteroscopic morcellator.
Read the Case Reivew (PDF)

Reviews in Obstetrics and Gynecology: Submucous Myoma

A 35-year-old woman (gravida 1, para 1) presented with excessive menstruation and secondary infertility.
Read the Article (PDF)

Complications of Hysteroscopy: A Prospective, Multicenter Study

Objective: To estimate the incidence of complications of diagnostic and operative hysteroscopic procedures in the Netherlands and describe their nature.
Read the Article (PDF)

Long-term Results of Hysteroscopic Myomectomy for Abnormal Uterine Bleeding

Objective: To analyze the efficacy of transcervical resection of submucous myomas and to identify prognostic factors for long-term results.
Read the Article (PDF)


REFERENCES

1.Phillips et al, 1995; Am Assoc Gynecol Laparosc, 2:147-53, J
2.Emanuel et al, 1999, Obstet Gynecol, Vol. 93, No. 5, Part 1, May 1999
3.Gallinat et al, 2008, JMIG (Abstracts), Vol. 15; S1-S159, AAGL 2008
4.Jansen et al, 2000, Obstet Gynecol, Vol. 96, No. 2, August 2000



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