Smith & Nephew Announces Favorable Results of TRUCLEAR 5.0 System

Smith & Nephew SNN, 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.