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.
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).
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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