A New Choice for Bariatric Surgeons:
Titan SGS™Standard Staple Line Reinforcement
with GORE®SEAMGUARD®Bioabsorbable Staple Line Reinforcement
WAYNE, Pa., Jan. 09, 2024 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the Titan SGS™ Stapler—the only purpose-built stapler for gastric tissue with a specific indication for sleeve pouch creation in bariatric procedures1—is now available with staple line reinforcement (SLR). This new option is designed to offer a choice for bariatric surgeons who prefer buttressing on every staple fire during sleeve gastrectomy. The Titan SGS™ Standard Staple Line Reinforcement received FDA 510(k) clearance on October 6, 2023,2 and is available for pre-order.
This buttressing combines the strengths of the Titan SGS™ Stapler with the confidence of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material and is designed to support staple line strength3 and help reduce leaks or bleeds.1,4-7 The Titan SGS™ Stapler is a 23cm, single-fire stapler designed to deliver more consistent and symmetrical sleeve anatomy by enabling the Standard Sleeve™ Technique, an anatomy-based approach to sleeve gastrectomy.1 GORE® SEAMGUARD® Reinforcement Material is the only*5 staple line reinforcement proven to significantly reduce leaks in sleeve gastrectomy procedures.4 This complimentary pairing supports bariatric surgeons. “Our focus is to provide bariatric surgeons with innovative solutions for sleeve gastrectomy. Our Titan SGS™ Standard Staple Line Reinforcement featuring GORE® SEAMGUARD® Reinforcement Material expands device selection for surgeons. This FDA clearance means that surgeons who prefer staple line reinforcement now have that option with the Titan SGS™ Stapler,” said James Ferguson, President and General Manager, Surgical, Teleflex Incorporated.
More than 10,000 sleeve gastrectomy procedures—laparoscopic and robotic-assisted—have been completed across the United States using the Titan SGS™ Stapler since its introduction to the market in 2021. Dr. Christina Sanders was the first surgeon to utilize the Staple Line Reinforcement and noted “The Titan SGS™ Stapler along with the Standard Staple Line Reinforcement helps support the security of the staple line and outcomes from my patients.”
Product Highlights
- Designed to protect against leaks. GORE® SEAMGUARD® Reinforcement Material has less than 0.39% leak rate in the U.S.5
- Engineered to protect against bleeding. The buttress conforms to the staple line anatomy and provides a matrix for blood to start clotting.3 This is designed to support the Titan SGS™ Stapler’s anatomy-based approach to sleeve gastrectomy.
- Designed to reduce bleeding complications. Randomized prospective data shows that GORE® SEAMGUARD® Reinforcement Material significantly reduces bleeding in standard and laparoscopic gastric bypass.6,7
For more information about the Titan SGS™ Standard Staple Line Reinforcement featuring GORE® SEAMGUARD® Reinforcement Material, or to learn more about the Titan SGS™ Stapler or the Standard Sleeve™ Technique, visit https://standardbariatrics.com/.
*Considering all systematic review and meta-analysis of published articles only that distinguish between types of staple line reinforcement as of January 2024.
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Teleflex is the home of Arrow™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
About W. L. Gore & Associates, Inc.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 10,500 Associates and a strong, team-oriented culture, Gore generates annual revenues of $4 billion. GORE and SEAMGUARD are trademarks of W. L. Gore & Associates. Visit: gore.com.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.
Teleflex, the Teleflex logo, Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, Standard Sleeve, Titan SGS, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2023 Teleflex Incorporated. All rights reserved.
References:
1. 510(k) No. K210278. The Titan SGS linear cutter is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation. 2021. Database Product Search (March 2023, Product Code: GDW).
2. Received FDA 510(k) clearance on October 6, 2023, classified as a class II device with the trade name Standard Staple-Line Reinforcement (SSLR23). 510(k) number K231603.
3. McCrea C. GORE® SEAMGUARD® Reinforcement Product Family: Relationship between Design Inputs and “Engineered to reduce the incidence of perioperative leaks and bleeding” Marketing Statement. Flagstaff, AZ; 2015. [Work plan]. WP107241
4. Gagner M, Kemmeter P. Comparison of laparoscopic sleeve gastrectomy leak rates in five staple-line reinforcement options: a systematic review. Surgical Endoscopy 2020;34(1):396-407 3
5. Data on file 2022; W. L. Gore & Associates, Inc; Flagstaff, AZ.
6. Miller KA, Pump A. Use of bioabsorbable staple reinforcement material in gastric bypass: a prospective randomized clinical trial. Surgery for Obesity & Related Diseases 2007;3(4):417-422
7. Nguyen NT, Longoria M, Welbourne S, Sabio A, Wilson SE. Glycolide copolymer staple-line reinforcement reduces staple site bleeding during laparoscopic gastric bypass. A prospective randomized trial. Archives of Surgery 2005;140(8):773-778.
Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
[email protected]
610-948-2836
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