Top-Line Data Show the Investigational TOPAS™ System Improves Fecal Incontinence in Women
The TOPAS™ System is an innovative, minimally-invasive approach to treating fecal incontinence, also known as accidental bowel leakage, or ABL. It uses a permanent mesh implant that is designed to restore and maintain anatomic support of the pelvic floor muscles. TOPAS™ is in development for women with ABL who have failed conservative therapy, which includes dietary changes, anti-diarrheal medications or bulking agents and pelvic floor muscle training. This is an investigational device whose efficacy and safety are not yet approved by the
"We are very excited and encouraged by the data shown in TRANSFORM and the potential future treatment option for women suffering from ABL," said
Due to the complexity of ABL, there is no standard treatment that fits all patients. In addition, treatments often place an additional burden on patients so newer and effective options are needed. Sustained improvements in bowel control with the TOPAS™ System exhibited in the TRANSFORM study suggest a promising outlook for a valuable therapeutic option for ABL.
The TRANSFORM study is a prospective, open-label, single-arm study involving 152 women implanted with the TOPAS™ system at 14 centers in
Overall, 69% of women experienced at least a 50% reduction in fecal incontinence episodes, exceeding the study's primary efficacy endpoint. Fecal incontinence episodes were reduced from a median weekly frequency of 9 episodes and 5 incontinence days at baseline, to 2.5 episodes and 2 incontinence days per week at 3, 6, and 12 months. In addition, patients reported an improvement in quality of life as indicated by validated questionnaires.
A total of 71 patients experienced 113 procedure and/or device (treatment-related) adverse events, 97% of which were managed without therapy or through non-surgical treatment. The most commonly observed complications (>5%) were pain (primary buttock, pelvic or groin pain) and incision site infection. There were no erosions, extrusions, organ perforations, bowel obstructions, or device revisions and no unanticipated adverse device effects observed in this study.
"Currently, there is no standard treatment that is suitable for all women suffering from ABL," said
About The TOPAS™ System
The TOPAS™ System is an implantable device intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies. The device is currently contraindicated for use in pregnant patients, patients with pre-existing conditions that pose an unacceptable surgical risk, patients with known sensitivity or allergy to polypropylene mesh products, and patients who are unwilling to abstain from receptive anal intercourse. Surgical revision or removal of the TOPAS device may involve multiple surgeries. Complete removal of the mesh may not be possible and may not result in complete resolution of the symptoms or complications.
Some of the most common risks (>5.0% incidence) include, but are not limited to: pain/discomfort in the buttock, groin and pelvic region, and incision site infection. Potential severe risks associated with this procedure may include, but are not limited to: perforation of the bowel, infection resulting in sepsis, allergic/hypersensitivity or other immune reaction, deep vein thrombosis, or erosion of the mesh through the rectum. Although rare, some mesh-related adverse events (e.g. mesh erosion/extrusion, mesh infection) may involve surgical intervention.
About American Medical Systems
American Medical Systems (AMS), headquartered in Minnetonka, MN, is a diversified supplier of medical device technology to treat incontinence, sexual dysfunction, benign prostatic hyperplasia (BPH) and other pelvic disorders. AMS is focused on improving access and outcomes with the goal of restoring patient quality of life. AMS is an operating company of
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. 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
2. Wu JM, Vaughan CP et al, Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014; 123(1):141–148) DOI: 10.1097/AOG.0000000000000057
3. Nandivada P, Nagle D, Surgical therapies for fecal incontinence. Curr Opin Gastroenterol. 2014; 30:69-74. DOI:10.1097/MOG.0000000000000029
4. Manchio JV, Sanders BM, Fecal incontinence: Help for patients who suffer silently. J of Family Practice. 2013; 62(11):640-650
SOURCE American Medical Systems
Investors/Media: Blaine Davis,+353-1-691-7579, (484) 216-7158, Investors: Jonathan Neely, (484) 216-6645, Media: Heather Zoumas-Lubeski, (484) 216-6829