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American Medical Systems Holdings Inc. Launches MiniArc™ Pro Single-Incision Sling System for Treatment of Female Stress Urinary Incontinence


7/23/2013 9:22:16 AM

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MINNEAPOLIS, July 22, 2013 /PRNewswire/ -- American Medical Systems® (AMS), Inc., an Endo Health Solutions Inc. (Nasdaq: ENDP) subsidiary and leading provider of devices and therapies for male and female pelvic health, today announced the U.S. launch of its MiniArc Pro single-incision sling system for the treatment of female stress urinary incontinence (SUI). The MiniArc Pro, the third generation of the MiniArc family, is designed with a new visual feedback system that gives the physicians the ability to objectively measure sling tension in a repeatable way to help find the most accurate placement for their patient.

"Slings are the surgical standard of care in treating women with stress urinary incontinence and a valuable treatment option for many women in the U.S. who suffer from this disruptive condition. However, continence slings I used previously did not provide an objective indicator of sling tension, which is different based on each patient," said Nathan Guerette, MD, FACOG, FAAFP, Director, The Female Pelvic Medicine Institute of Virginia, Associate Clinical Professor, Division of Urogynecology and Pelvic Reconstructive Surgery, Medical College of Virginia. "With the advancements in the MiniArc Pro system, I'm now able to objectively measure and record the sling tension for each patient."

Bladder leakage, also known as urinary incontinence, is the loss of bladder control or involuntary loss of urine. SUI is the most common type of urinary incontinence, which results in the accidental loss of urine when coughing, laughing, sneezing or during heavy lifting, or simply getting up from a chair.1,2 More than 13 million women in the United States suffer from SUI.3

"At AMS, we are committed to providing world-class medical devices that improve patients' quality of life," said Camille Farhat, AMS president. "The MiniArc family of single-incision slings is the leading mini-sling therapy line in the United States, offering physicians and their patients a minimally-invasive option to treat female stress urinary incontinence. We continue to design products such as the MiniArc Pro system to enhance procedural success and patient outcomes. AMS supports its products with robust physician training and we encourage physician-patient conversations on the risks and benefits of these therapies."

MiniArc sling systems were first introduced in 2007 and have been used by more than 168,000 patients worldwide. The MiniArc Pro sling system was designed based on the AMS MiniArc and MiniArc Precise sling systems, which have shown to have a success rate of 85 to 94 percent at 12 months across multiple studies, including a prospective, multi-center study.4-10

To evaluate the performance of MiniArc sling systems and other Women's Health products, the company is conducting CAPTURE, a prospective, multi-center, observational long term registry of female patients who are implanted with at least one AMS market approved pelvic health product. CAPTURE is registered with ClinicalTrials.gov.

The MiniArc Pro single-incision sling system has U.S. FDA clearance. More information is available at www.amsminiarc.com.

As with all mesh sling surgical procedures, there are risks and potential complications that may occur. Please consult a physician before considering surgery.

About MiniArc ProTM

The MiniArc Pro Single-Incision Sling System is intended for the placement of a sub-urethral mesh for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsicsphincter deficiency (ISD). MiniArc Pro is contraindicated in patients who are pregnant, have active infection or signs of tissue necrosis, have known sensitivity or allergy to propylene mesh products or in patients with pre-existing conditions that pose unacceptable surgical risk. Tissue responses to the sling may include vaginal extrusion, erosion through the bladder or other surrounding tissue, migration of the device from the desired location, contracture, fistula formation and/or inflammation. These occurrences may require removal or revision of the sling.

About American Medical Systems

American Medical Systems (AMS), headquartered in Minnetonka, Minn., is a diversified supplier of medical devices and procedures to treat benign prostatic hyperplasia (BPH), incontinence, sexual dysfunction, and other pelvic disorders in men and women. AMS continues to develop new therapies to restore bodily functions and to enable people to regain control of their lives. These therapies provide new options for patients, providers and payers, and are often inspired by the urologists, gynecologists and urogynecologists who choose AMS as their solutions partner. AMS is an operating company of Endo Health Solutions Inc. (NASDAQ: ENDP), a specialty healthcare company with four distinct business segments focused on branded and generic pharmaceuticals, devices and services, each providing quality products to customers and improving the lives of patients. Learn more at www.endo.com .

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in Endo Health Solutions' Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in the Endo Health Solutions Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

1. WebMD.com. Retrieved from http://www.webmd.com/urinary-incontinence-oab/america-asks-11/stress.

2. FDA.gov. What is Stress Urinary Incontinence. Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm284109.htm.

3. WebMD. Retrieved from http://www.webmd.com/urinary-incontinence-oab/america-asks-11/stress.

4. Kennelly MJ, Moore R, Nguyen JN, Lukban J, Siegel S. Miniarc® single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes. [published online ahead of print Apr 20, 2012]. Int Urogynecol J.

5. Kennelly MJ, Moore R, Nguyen JN, Lukban JC, Siegel S. Prospective evaluation of a single incision sling for stress urinary incontinence. J Urol. 2010;184(2):604-9.

6. Richter HE, Albo ME, Zyczynski HM et al. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010;362(22):2066-76.

7. Oliveira R, Botelho F, Silva P et al. Exploratory Study Assessing Efficacy and Complications of TVT-O, TVT-Secur, and Mini-Arc: Results at 12-Month Follow-Up. Eur Urol 2011;01(2 suppl):145.

8. Moore RD, Mitchell GK, Miklos JR. Single-Center Retrospective Study of the Technique, Safety, and 12-Month Efficacy of the iniArc Single-Incision Sling: A New Minimally Invasive Procedure for Treatment of Female SUI. Surg Technol Int. 2009;18:175-81.

9. De Ridder D, Berkers J, Deprest J, et al. Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc and Monarc slings. Int Urogynecol J. 2010;21(7):773

10. Pickens RB, Klein FA, Mobley JD, III, and White WM, Single Incision Mid-urethral Sling for Treatment of Female Stress Urinary Incontinence. Female Urol 2011:181(4 suppl):544

SOURCE American Medical Systems



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