American Medical Systems Receives FDA 510(k) Clearance
American Medical Systems Receives FDA 510(k) Clearance of the RetroArc™ Retropubic Sling System for Treatment of Female Stress Urinary Incontinence
RetroArc Extends the AMS™ Continence Sling Portfolio to Provide More Options for Women With SUI
MINNEAPOLIS, Dec. 9, 2013 /PRNewswire/ -- American Medical Systems® Inc. (AMS), an Endo Health Solutions Inc. (Nasdaq: ENDP) subsidiary and leading provider of devices and therapies for male and female pelvic health, today announced FDA 510(k) Clearance of its RetroArc™ Retropubic Sling System for treatment of female stress urinary incontinence (SUI). Developed in collaboration with leading physicians, this system maintains familiar features of transvaginal retropubic sling systems while incorporating new enhancements and the ability to make fine-tuned adjustments to better meet the needs of physicians.
With the launch of the RetroArc System, AMS provides a comprehensive portfolio of female continence products, including Minislings that offer a single-incision approach; Transobturator Slings that facilitate an "outside in" approach; and Retropubic Slings that allow surgeons to take a "top down" or 'bottom up" transvaginal retropubic approach.
"FDA Clearance of the RetroArc Retropubic Sling System rounds out the AMS family of slings," says Steve Blum, AMS general manager of Women's Health. "It underscores our commitment to physicians and patients for the treatment of female stress urinary incontinence, and builds on our leadership in Women's Health."
More than 13 million women in the United States suffer from SUI.1 Slings are the surgical standard of care in treating these women.2,3 The RetroArc Retropubic Sling System is designed with time-tested AMS™ mesh with a patented adjustment suture; carefully considered needles; and ergonomic, quick-release handle designed to maximize comfort and control for the physician during the procedure.
"I found the RetroArc Retropubic Sling System to be easy to use," said Dr. Neeraj Kohli of Newton Wellesley Hospital and Brigham and Women's Hospital, Boston, MA who performed the first US implant of the sling on December 2 nd. "It combines all the positive features of retropubic sling systems into one well-designed solution. I look forward to using the RetroArc System with more of my patients who suffer from female stress urinary incontinence."
"At AMS, we are committed to providing world-class medical devices that improve patients' quality of life," said Camille Farhat, AMS president. "The RetroArc Retropubic Sling System is another example of how AMS innovates to provide world-class medical devices for patients around the world," said Farhat. "We support our products with robust physician training and we encourage physician-patient conversations on the risks and benefits of these therapies."
More information on the RetroArc Retropubic Sling System is available at: www.visitams.com/prof_female_retroarc.html.
As with all mesh sling surgical procedures, there are risks and potential complications that may occur. Please consult a physician before considering surgery
About the RetroArc Retropubic Sling System
The RetroArc Retropubic Sling System is designed to treat women with incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency. It 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. Although rare, some of the most severe risks with sling procedures include infection, erosion and vessel or urethra perforation. Some of the most common risks include urinary tract infections, urge symptoms and urinary retention.
About Stress Urinary Incontinence
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.4
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.
WebMD.com. Retrieved from http://www.webmd.com/urinary-incontinence-oab/america-asks-11/stress.
Lee EW, Nitti VW, Brucker BM, Midurethral slings for all stress incontinence: A urology perspective, Urol Clin N Am 2012, 39:99-310, DOI: 10.1016/j.ucl-2012-05-003.
Khan FN, Hamid A, Wazir BS, Wani MS, Ahmad Z, An evaluation of use of trans-obturator tape (TOT) sling procedure in the current surgical management of femalestress urinary incontinence, Int J of Health Sciences, 2008, 2(2):118-125.
FDA.gov. What is Stress Urinary Incontinence. Retrieved from
SOURCE American Medical Systems
CONTACT: Investors/Media: Blaine Davis, (484) 216-7158; Investors: Jonathan Neely, (484) 216-6645; Media: Brian O'Donnell, (484) 216-6726
Web Site: http://www.endo.com
Posted: December 2013