Medical Device Daily Contributing Writer

CHICAGO – The push toward less-invasive gynecologic procedures continued to be much in evidence during the 29th annual meeting of the American Urogynecologic Society (AUGS; Washington).

As with advances in pelvic organ prolapse procedures (Medical Device Daily, Sept. 18, 2008), traditional treatment for stress urinary incontinence, which affects 12 million Americans, has been with complicated surgeries.

Since the introduction of transvaginal tape (TVT) in 1996, these surgeries have been replaced by the use of kits that contain a sling, or mesh, that is placed under the urethra for support, and that utilizes one vaginal incision and two small abdominal incisions rendering it a much less invasive procedure and with equal or higher success rates of 85% to 95%.

Initially introduced by Ethicon Women's Health and Urology (Somerville, New Jersey), American Medical Systems (AMS; Minnetonka, Minnesota) followed close behind in 2001 with its Transobturator Tape (TOT) sling and then was followed by several other manufacturers — including Caldera, C.R. Bard (Murray Hill, New Jersey), Boston Scientific (Natick, Massachusetts), Coloplast (Minneapolis), Endogun Medical Systems (Kibbutz Haogen, Israel) and Mpathy Medical (Raynham, Massachusetts), each with variations on the theme

Again, in an effort to make them even less invasive and a potential outpatient procedure, the mini-sling procedure was released in the U.S. in late 2006 by Ethicon Women's Health under the name TVT-Secure, followed by the March 2007 release of the AMS mini-sling, called the Mini-Arc.

Yitzach Asulin, MD, of the department of obstetrics and gynecology at Stamford Hospital (Stamford, Connecticut) reported in a poster presentation, "Short-Term Efficacy and Safety of the Miniarc: a Single Incision Sling vs. the Tension-Free Vaginal Tape Secur System in Women with Stress Incontinence," on a study in which eight patients were treated with the Secur mini-sling and eight with the Miniarc mini-sling.

He found that "both the TVT S and the Miniarc single-incision sling procedures appeared to be equally effective as surgical treatment of stress urinary incontinence in women. There appeared to be minimal complications, as these procedures were proven to be relatively safe with good short-term efficacy."

The next step in this evolutionary process would be to determine the feasibility of pain management in an office setting.

Michael Woods, MD, associate clinical professor at the University of Nebraska Medical Center (Omaha, Nebraska), assessed the feasibility of in-office placement of the Secur mini-sling under local anesthetic and reported his findings in a poster presentation titled "Vaginal Sling for Stress Urinary Incontinence Under Local Anesthetic in the Office Setting."

Woods said, "It appears that single-incision vaginal mini-slings are well-tolerated in the office setting with the use of local anesthetic only."

In another poster presentation, this one using the AMS mini-sling, M.J. Kennelly, MD, of McKay Urology (Charlotte, North Carolina), discussed "An Early Clinical Evaluation of the Miniarc Performed Under General or Local Anesthesia for the Treatment of Stress Urinary Incontinence."

He said, "Early data suggest the MiniArc can be performed under local anesthesia. Results of subjects under local anesthesia in comparison to those under general anesthesia showed shorter facility stay with minimal complications and little post-operative pain."

Given these early positive reports on less-invasive treatments for both pelvic organ prolapse and stress urinary incontinence, it was not surprising to see two new entries into this space.

One is Endogun Medical Systems (Kibbutz Haogen, Israel) with its line of soft tissue fasteners for use with mesh for totally transvaginal POP and SUI procedures.

Endogun leapfrogged directly into transvaginal procedural kits without evolving through the minimally invasive abdominal trocar insertion route first employed by established companies in urogynecology. FDA clearance was received this past April, followed by their product launch at this meeting.

This privately held company is seeking marketing partners for its line of products.

The other newcomer is Mpathy Medical (Raynham, Massachusetts), which launched its product line in the U.S. in May and exhibited for the first time at AUGS.

The company has developed a line of ultra-light mesh products specifically for urogynecology procedures that have been tested in more than 8,000 cases and claims to have near-zero erosion rates and complications.

Once data has been collected on these new procedures using transvaginal techniques over longer periods of time, and once efficacy and pain management can be demonstrated in an office setting, all that will be required is in-office reimbursement in order to drive this market and attract the hundreds of thousands of women who refuse to enter a hospital for a "female problem."

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