Smith & Nephew has announced the launch of its Truclear 5.0 System, according to the company the smallest hysteroscopic morcellator system to receive FDA 510(k) clearance. With an outer diameter of only 5.0 mm, this patient-friendly instrumentation allows surgeons to safely and thoroughly remove intrauterine polyps and uterine fibroids under continuous visualisation.
Current industry estimates show that 10% 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. As women enter menopause, the frequency of polyps increases and as many as 4-6% of these polyps are atypical or malignant.
Since its 2005 introduction, the Truclear System has been used in more than 40,000 procedures worldwide. The Truclear 5.0 System builds on this success by continuing to pair the visualisation capabilities of a hysteroscope with minimally invasive, 100% tissue removal in the smallest single-insertion device available.
While the majority of these procedures will continue to be performed in traditional operating rooms, the Truclear 5.0 System’s smaller size now provides surgeons with the potential of using it in the office or clinical setting as well.
Already proving successful in Europe
Backed by more than a year of use in Europe, the Truclear 5.0 System has been receiving accolades from European obstetricians and gynecologists. In fact, a pre-launch evaluation showed that 100% of surgeons said this was their preferred tool for polypectomies due to its smaller size. “I could not have obtained these results with any other device,” said Dick C. Schoot, M.D., Catharina Hospital, Netherlands after a successful polypectomy.
“The Truclear 5.0 System combines safety, precision, and ease in the treatment of endometrial polyps and small uterine fibroids,” explains Dr. Charles Miller, Past President of the American Association of Gynecologic Laparoscopists (AAGL) and President, the International Society for Gynecologic Endoscopy (ISGE) in Naperville, Ill. “With this less invasive technology, I am looking forward to using TRUCLEAR right in my office – this is especially ideal for my fertility patients whom I prefer not to dilate.”
Mira Sahney, General Manager, Gynecology for Smith & Nephew stated, “We are excited to offer this game-changing minimally invasive technology. At 20-percent smaller than other hysteroscopes, Truclear 5.0 System has the potential to reduce gynecology healthcare costs across the United States by allowing procedures to be performed in an office setting.”
Source: Smith & Nephew, PR Newswire