2014

New clinical study demonstrates TRUCLEAR◊ 5.0 System as a favorable treatment for a common gynecological condition, right in the doctor's office

LONDON, April 24, 2014 /PRNewswire/ -- Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, today announces the results of a new multicenter clinical study which compares the TRUCLEAR 5.0 System with the VersaPoint Bipolar Electrosurgery System for the removal of endometrial polyps. A common gynecologic disorder that can affect as many as 35% of womeni, endometrial polyps are a leading cause of abnormal uterine bleeding. According to the study in this month's edition of Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists (ACOG), the TRUCLEAR 5.0 System was significantly quicker, generally less painful and more acceptable to women in an office setting when compared with VersaPoint.i[i]

While authors reported both methods to be safe options for removing polyps from the uterine walls, they pointed to the ability of the TRUCLEAR 5.0 System to both cut and extract polyps without the time-consuming use of additional instrumentation, as well as its ability to provide improved visualization as key differentiators.

"As pioneers in minimally-invasive gynecology, this study is an important confirmation of our efforts to provide women with improved options for intrauterine tissue removal," explains Mira Sahney, VP and General Manager, Gynecology for Smith & Nephew. "This clinical study demonstrates the potential for the TRUCLEAR System to be used as a treatment option in a more convenient and comfortable setting for women."

Additional findings of the study – which was awarded the Golden Hysteroscope Award for "Best Paper on Hysteroscopy" at the 42nd Annual Global Congress on Minimally Invasive Gynecology (AAGL) – include:

  • The TRUCLEAR 5.0 System was quicker and less painful in removing endometrial polyps when compared with electrical resection.
    • The TRUCLEAR System was shown to reduce polypectomy procedure time by 47% in an office setting when compared to VersaPoint.
    • Patients undergoing the procedure with the TRUCLEAR System reported 31% lower average pain scores than those undergoing the procedure with electrical resection.
  • The TRUCLEAR 5.0 System demonstrated the ability to completely resect polyps larger than 2 cm in the office setting.
  • The TRUCLEAR 5.0 System demonstrated an average resection time of 79 seconds for polyps in an office setting.

The data generated by this study comes on the heels of newly expanded Indications for Use for the TRUCLEAR System. In addition to the removal of polyps and submucosal fibroids, the system is now indicated for the removal of intrauterine tissues such as retained products of conception.

Attendees at this month's American College of Obstetricians and Gynecologists (ACOG) meeting in Chicago can learn more about the study and the improved quality of life that the TRUCLEAR System has brought to over 100,000 women by visiting the Smith & Nephew booth (#1508) or www.sntruclear.com.

About the TRUCLEAR System:
The innovative TRUCLEAR System has become a gold standard in polyp and fibroid removal. The TRUCLEAR System removes intrauterine tissue through mechanical cutting coupled with simultaneous tissue aspiration, and requires no incisions or electrical energy to be used inside the uterus. Given the minimally-invasive nature of the TRUCLEAR System, this procedure can be performed in the gynecologist's office or an outpatient setting, allowing many women to return to normal activities the next day. The TRUCLEAR System is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception. The TRUCLEAR System is also designed for Visual D&C, Endometrial Biopsy and Hysteroscopic Adhesiolysis.

Editor's Notes:
Current estimates show that as many as 35% of women may have endometrial polyps – a condition that has been cited as a cause of infertility. Women with polyps frequently suffer from irregular bleeding or postmenopausal bleeding.i 

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 11,000 employees and a presence in more than 90 countries. Annual sales in 2013 were more than $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

For more information about Smith & Nephew Gynecology, please visit our website www.sntruclear.com, follow @SmithNephew on Twitter or visit Smith & Nephew USA on Facebook.com

Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations.

Trademark of Smith & Nephew. Registered US Patent and Trademark Office. All Trademarks acknowledged.

iAAGL Practice Report: Practice Guidelines for the Diagnosis and Management of Endometrial Polyps. Journal of Minimally Invasive Gynecology (2012) 19, 3–10.
i[i]Smith PP et al. Hysteroscopic morcellation compared with electrical resection of endometrial polyps: A randomized controlled trial. Obstet Gynecol 2014 Apr; 123:745

SOURCE Smith & Nephew



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