Teleflex now offers its Titan SGS™ Stapler with Staple Line Reinforcement

Rhea-AI Summary

Teleflex Incorporated (NYSE: TFX) announced the availability of Titan SGS™ Standard Staple Line Reinforcement with GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement, a new option for bariatric surgeons. The product is designed to support staple line strength and reduce leaks or bleeds, expanding device selection for surgeons. The FDA clearance for this product means that surgeons who prefer staple line reinforcement now have that option with the Titan SGS™ Stapler.

Medical Device Analyst

Teleflex Incorporated's introduction of the Titan SGS™ Stapler with staple line reinforcement (SLR) represents a significant innovation in the medical device sector, specifically within the realm of bariatric surgery. The integration of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is poised to enhance surgical outcomes by reducing complications such as leaks and bleeding, which are critical factors in postoperative recovery and patient satisfaction. By offering a product that is purpose-built for gastric tissue and sleeve pouch creation, Teleflex is addressing a niche but growing market segment.

From a financial perspective, this FDA-approved product expansion could potentially increase market share and drive revenue growth for Teleflex. The bariatric surgery devices market has been expanding due to rising obesity rates globally and innovations that promise improved patient outcomes tend to be well-received by healthcare providers. The specific indication for sleeve pouch creation, coupled with the product's design to deliver more consistent and symmetrical sleeve anatomy, suggests that Teleflex is leveraging product differentiation as a competitive strategy.

Moreover, the clinical data supporting the efficacy of the GORE® SEAMGUARD® Reinforcement Material in reducing leaks and bleeding presents a compelling value proposition to surgeons and hospitals. The product's adoption could be further facilitated by the existing user base of over 10,000 procedures with the Titan SGS™ Stapler, which may provide a ready market for the new reinforced version. However, market penetration rates and the long-term adoption of the new product will hinge on the comparative performance of the reinforced stapler against existing alternatives and the cost-effectiveness for healthcare providers.

Healthcare Economist

The introduction of the Titan SGS™ Stapler with SLR by Teleflex is a development that may have broader economic implications within the healthcare industry. By potentially reducing complication rates in sleeve gastrectomy procedures, this product could lead to a decrease in overall healthcare costs associated with postoperative care, readmissions and extended hospital stays. A lower complication rate translates into economic benefits for both healthcare providers and payers, including insurance companies and government healthcare programs.

Furthermore, the healthcare system's shift towards value-based care, where reimbursement is increasingly tied to patient outcomes, underscores the importance of such innovations. Products that contribute to better surgical outcomes can align with these value-based care models, potentially leading to preferential adoption by healthcare systems and influencing reimbursement policies.

However, it is essential to consider the initial cost of the product and the cost-benefit ratio. If the price point of the Titan SGS™ with SLR is significantly higher than non-reinforced alternatives, hospitals and surgical centers may weigh the potential savings from reduced complications against the upfront costs. In the long run, widespread adoption will depend on whether the economic benefits of using the reinforced stapler outweigh the initial investment from a total cost of care perspective.

Surgical Outcomes Researcher

The clinical significance of Teleflex's Titan SGS™ Stapler with SLR cannot be overstated in the context of surgical outcomes research. The product's design, which is tailored for a specific surgical procedure, reflects a trend towards personalized medical devices that cater to the intricacies of individual surgical techniques. The use of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is particularly noteworthy, as it is the only reinforcement material proven to significantly reduce leaks in sleeve gastrectomy procedures.

Randomized prospective data that supports the efficacy of the material in reducing bleeding complications provides a strong foundation for its clinical use. However, it is crucial for ongoing post-market surveillance to monitor the long-term safety and effectiveness of the product. Real-world data will be vital in assessing whether the observed reduction in leaks and bleeding complications in clinical trials translates into tangible benefits in diverse patient populations and surgical settings.

Additionally, the surgeon's perspective, as highlighted by Dr. Christina Sanders' positive feedback, is a key factor in the adoption of new surgical technologies. Surgeon endorsement can drive product uptake, but it is also essential to evaluate the learning curve associated with the new technology and the potential need for additional training or adjustments in surgical technique.

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
investor.relations@teleflex.com      
610-948-2836

What did Teleflex Incorporated announce?

Teleflex Incorporated announced the availability of Titan SGS™ Standard Staple Line Reinforcement with GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement.

What is the ticker symbol for Teleflex Incorporated?

The ticker symbol for Teleflex Incorporated is TFX.

What is the purpose of the Titan SGS™ Standard Staple Line Reinforcement?

The Titan SGS™ Standard Staple Line Reinforcement is designed to support staple line strength and reduce leaks or bleeds in bariatric procedures.

When did the Titan SGS™ Standard Staple Line Reinforcement receive FDA clearance?

The Titan SGS™ Standard Staple Line Reinforcement received FDA 510(k) clearance on October 6, 2023.

How many sleeve gastrectomy procedures have been completed using the Titan SGS™ Stapler?

More than 10,000 sleeve gastrectomy procedures have been completed across the United States using the Titan SGS™ Stapler since its introduction to the market in 2021.

Who was the first surgeon to utilize the Staple Line Reinforcement?

Dr. Christina Sanders was the first surgeon to utilize the Staple Line Reinforcement and noted its benefits in supporting the security of the staple line and outcomes from her patients.