NATICK, Mass., June 15 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that results from nine studies involving the Company's Urology/Gynecology products will be presented at the 34th Annual Meeting of the International Urogynecological Association (IUGA). Presentations will feature Boston Scientific's pelvic floor reconstruction systems and mid-urethral sling systems used to treat pelvic floor prolapse and stress urinary incontinence (SUI). The Company will also sponsor a symposium highlighting long-term registry data comparing the benefits of experienced-based versus evidence-based outcomes for patients treated with mid-urethral slings. The IUGA Congress will be held June 16-20 at the Villa Erba Conference Center in Como, Italy.
Schedule of Key Presentations (all times are local Como, Italy)
Thursday, June 18
Randomized Clinical Trial of Trans-Obturator Tape Versus Tension-Free Vaginal Tape Procedure for the Surgical Management of Stress Incontinence in Women: Outcomes at 12 Months Postoperatively - Magali Robert, M.D.
This study compared one-year outcomes in women randomized for surgical treatment of stress incontinence using Trans-Obturator Tape (TOT) or Tension-free Vaginal Tape (TFVT) procedures. Results will be presented during a podium session at 9:00 a.m.
Short-Term Outcomes and Peri-Operative Events After a New Transvaginal Anterior and Apical Mesh Repair - Dennis P. Miller, M.D.
This study evaluated short-term functional and anatomical outcomes and all peri-operative adverse events of the first procedures performed with a transvaginal, trocar-free, grafted prolapse repair kit (Pinnacle(R) Pelvic Floor Repair device). Results will be presented during a video with data session at 1:30 p.m.
Comparison of Transvaginal Mesh System Placement for Support of Anterior and Apical Compartments in a Cadaver Model - Dennis P. Miller, M.D.
This study is designed to evaluate the degree of apical support of graft-reinforced pelvic floor repair (PFR) systems in the anterior compartment that use either the SSL (Pinnacle Pelvic Floor Repair) or ATFP fixation (Anterior Gynecare Prolift(R) Mesh; Perigee(R) Sling; Anterior Avaulta Solo(R) Introducer). The study also compared distances of major anatomical structures from sacrospinous apical pelvic floor repair systems implanted transvaginally in either the anterior compartment via an intravaginal mesh delivery device (Pinnacle) or posterior compartment using a trocar-based system (Anterior Gynecare Prolift Mesh; Posterior Avaulta Solo Introducer). Results will be presented during an oral poster session at 2:00 p.m.
Friday, June 19
Anterior Sacrospinous Ligament Fixation Associated with Paravaginal Repair Using the Pinnacle Device: An Anatomical Study - Renaud de Tayrac, M.D.
This study evaluates the reproducibility and anatomical risks after anterior sacrospinous ligament fixation associated with paravaginal repair using the Pinnacle Pelvic Floor Repair device. Results will be presented during an oral poster session at 4:00 p.m.
Symposium on Clinical Excellence and Product Innovation for SUI and PFR
This Boston Scientific-sponsored symposium will present new long-term data from the international mid-urethral sling registry, which assesses patient outcomes with the Obtryx(R) System and Advantage(R) System. Panelists will discuss the benefits of experienced-based versus evidence-based clinical data. Presenters will also address current and emerging surgical techniques for the management of apical and anterior prolapse repair, providing an overview of the evolution of the procedure. The symposium will take place from 5:00-6:00 p.m. in Room R01.
Saturday, June 20
Multicentric Comparison of Efficacy of Transobturator Tape in Women with Intrinsic Sphincter Deficiency and without ISD from International Registry - Anga S. Arunkalaivanan, M.D.
This study compares the efficacy of transobturator tape (Obtryx System) in the treatment of stress urinary incontinence in women with intrinsic sphincter deficiency (ISD) and non-ISD. Results will be presented during an oral poster session at 11:00 a.m.
Poster Presentations (available during daily exhibit hours in the Lario Wing)
Boston Scientific Urology Gynecology offers products for pelvic floor reconstruction, including the Pinnacle(R) Pelvic Floor Kit Devices and the Uphold(TM) Vaginal Support System. In addition, the Company offers a complete line of mid-urethral sling systems for the treatment of stress urinary incontinence, including the Obtryx(R) Transobturator Mid-Urethral Sling System and the recently launched Solyx(TM) Single Incision Sling System.
Gynecare Prolift(R) is a registered trademark of Johnson & Johnson Corporation. Perigee(R) is a registered trademark of AMS Research Corporation. Avaulta Solo(R) is a registered trademark of C.R. Bard, Inc.
* Denotes that Boston Scientific product is not cleared for this indication in the U.S.
IUGA is a non-profit international organization dedicated to the advancement of urogynecological knowledge around the world through education and the promotion of basic and clinical research on disorders of the female pelvic floor. For more information, please visit www.iuga.org.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things our product performance, regulatory approval of our products, clinical studies, competitive offerings, our growth strategy, and our market position. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A - Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
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