Healthcare Industry News:  hysteroscope 

Devices FDA

 News Release - June 6, 2012

TRUCLEAR(TM) 5.0 System offers US surgeons a patient-friendly option for removing intrauterine polyps in office or clinical setting

LONDON, June 6, 2012 -- (Healthcare Sales & Marketing Network) -- Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, announces its TRUCLEAR 5.0 System, the smallest hysteroscopic morcellator system(1) to receive 510(k) clearance from the FDA, is now available to US surgeons nationwide. 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 visualization. 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.

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.

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.

"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."

Since its 2005 introduction, the TRUCLEAR System has been used in more than 40,000 procedures worldwide. Building on this global record of success, the TRUCLEAR 5.0 System continues to pair the visualization capabilities of a hysteroscope with the minimally invasive, 100% tissue removal in the smallest single-insertion device available.

(1) Compared to competitive products.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Annual sales in 2011 were nearly $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In particular, statements regarding planned growth in our business and in our operating margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline. These statements, as well as the phrases "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions, are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. 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 20F, for a discussion of certain of these factors.

All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Source: Smith & Nephew

Issuer of this News Release is solely responsible for its content.
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