New Retrospective Study Reports Significantly Reduced Post-Operative GERD Rates with the Titan SGS™ Stapler from Teleflex Compared with Multi-Fire Staplers in Sleeve Gastrectomy

Rhea-AI Summary

A new retrospective study published in Obesity Surgery highlights significant benefits of Teleflex's (NYSE: TFX) Titan SGS™ Stapler in sleeve gastrectomy procedures. The study of 257 patients showed that at one-year post-procedure, patients treated with the Titan SGS™ Stapler experienced significantly lower rates of GERD (7.1% vs 26.4%) and de novo GERD (1.8% vs 10.9%) compared to multi-fire staplers. The Titan SGS™ Stapler, being the first and only single-fire surgical stapler specifically designed for sleeve gastrectomy, features a 23cm continuous staple line that creates consistent tubular sleeve anatomy. The study demonstrated that GERD resolution was higher in the Titan SGS™ cohort (25% vs 10.9%), while maintaining equivalent weight loss outcomes (approximately 22%) compared to traditional multi-fire staplers.

Positive

• Significantly lower GERD rates with Titan SGS™ Stapler (7.1%) vs multi-fire staplers (26.4%)
• Lower de novo GERD rates with Titan SGS™ (1.8%) vs multi-fire staplers (10.9%)
• Higher GERD resolution rate in Titan SGS™ cohort (25%) vs multi-fire cohort (10.9%)
• First and only single-fire surgical stapler specifically designed for sleeve gastrectomy
• Maintains equivalent weight loss outcomes while improving GERD-related complications

Negative

• None.

Insights

Medical Device Analyst

Teleflex's Titan SGS™ Stapler shows significant clinical advantages in bariatric surgery, potentially driving adoption and market share gains.

The newly published retrospective study comparing Teleflex's Titan SGS™ Stapler to traditional multi-fire staplers demonstrates compelling clinical advantages that could significantly impact TFX's competitive position in the bariatric surgery market. With sleeve gastrectomy being the most common weight-loss surgery in the U.S., the reduction in post-operative GERD rates (from 26.4% to just 7.1%) addresses a major clinical challenge in these procedures.

The data highlights three key differentiators: significantly fewer patients developing new-onset GERD (1.8% vs. 10.9%), higher resolution rates of pre-existing GERD (25% vs. 10.9%), and equivalent weight loss outcomes (22.0% vs. 22.4%). Most importantly, these improvements come without compromising the primary therapeutic goal of the procedure.

The Titan SGS™ Stapler's unique 23cm continuous staple line creates a more anatomically consistent sleeve shape, addressing what has been a technical limitation in bariatric surgery where ideal tubular anatomy is achieved less than 40% of the time. This study builds on previous research showing the device also reduces operative times and post-operative complications.

While this is retrospective data from procedures performed by a single surgeon, the significant GERD reduction represents a meaningful clinical advantage that could expand Teleflex's market share in the competitive surgical stapler segment, particularly as bariatric surgery volumes continue to grow amid rising obesity rates.

Data also demonstrate significantly lower rates of postoperative reflux and decreased incidence of de novo gastroesophageal reflux disease (GERD) without affecting total weight loss at 1-year*, and shorter average hospital length of stay (LOS) associated with use of the Titan SGS™ Stapler compared with multi-fire staplers¹

WAYNE, Pa., May 13, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the publication of a new retrospective analysis of clinical data associating the use of the Titan SGS™ Stapler with reduced rates of post-operative GERD following robotic-assisted laparoscopic sleeve gastrectomy (LSG) compared with traditional multi-fire surgical staplers.¹ The retrospective study comprised 257 patients who underwent robot-assisted sleeve gastrectomy using the Titan SGS™ Stapler or multiple fires of a traditional linear stapler between 2016 and 2023. All procedures included in the study were performed by a single surgeon.¹ The study has been published online in Obesity Surgery.¹

Sleeve gastrectomy is the most common weight-loss surgery in the U.S.² While the procedure is associated with a low rate of adverse events during and following surgery, a 2024 review of 109 studies found “a persistent concern for worsening and de novo GERD” after sleeve gastrectomy.³ Pouch shapes based on anatomical landmarks have previously been shown to help reduce the incidence of GERD⁴ but highly variable surgical techniques and multiple stapler fires yield inconsistent pouch anatomy.⁵ Consequently, one study found that bariatric surgeons have been able to achieve the ideal tubular sleeve anatomy less than 40% of the time, resulting in inconsistent patient outcomes, including GERD and nausea.⁵

“Improving clinical outcomes for patients — including the development of post-operative GERD — may be important for wider adoption of bariatric surgery, which remains the most effective and durable obesity treatment,” said Forrest Ringold, MD, FACS, SAGES, an expert in bariatric and robotic surgery at the Surgical Association of Mobile and senior researcher on the publication. “This study shows that GERD was less common in LSG procedures that used the Titan SGS™ Stapler. I believe this is because the 23cm single-fire Titan SGS™ Stapler is intentionally designed to enable more consistent and symmetrical sleeve anatomy and to provide reproducible pouch anatomies from patient to patient.⁶ This study adds to a growing body of evidence supporting the potentially enhanced perioperative benefits linked to the Titan SGS™ Stapler in sleeve gastrectomy.”

The Titan SGS™ Stapler is the first and only single-fire, surgical stapler designed and indicated specifically for sleeve gastrectomy pouch creation.⁶ As the only stapler to provide a 23cm staple line — the industry’s longest continuous staple cutline —the Titan SGS™ Stapler is designed to provide an ideal tubular surgical sleeve anatomy that is a consistent shape, free of kinks, twists, or spirals, improving the potential to resolve GERD and nausea.^4,7

The publication reports retrospective observational data that at one-year post-procedure, significantly fewer patients in the Titan SGS™ Stapler cohort reported having GERD (7.1%) compared with the multi-fire cohort (26.4%) (p = 0.002) and significantly fewer patients in the Titan SGS™ Stapler cohort developed de novo GERD (1.8%) compared with the multi-fire cohort (10.9%) (p = 0.005). Additionally, more patients in the Titan SGS™ Stapler cohort who had GERD prior to the procedure saw resolution of this condition, compared to the multi-fire cohort (25% vs. 10.9%, p = 0.005). Notably, the improvements in GERD outcomes linked to the Titan SGS™ Stapler were achieved without a significant difference in weight loss at 1 year between the two cohorts (multiple-fire: 22.4% ± 0.7%, single-fire: 22.0% ± 1.7%, p = 0.8).*

“The Titan SGS™ Stapler was developed to enable more consistent and symmetrical sleeve anatomy because we believe that sleeve shape significantly contributes to sleeve gastrectomy efficacy and safety outcomes,” said James Ferguson, President and General Manager, Surgical, at Teleflex. “The study’s authors hypothesize that the improved GERD outcomes reported in the Titan SGS™ Stapler cohort may be because the 23cm single-fire continuous staple line without overlapping staple firings ‘results in less kinking along the sleeve staple line, which prevents inadvertent narrowing’. This suggests that consistent sleeve shape may play a role in reducing GERD.”

In previous retrospective studies, the Titan SGS™ Stapler has been associated with significantly reduced operative times,⁸ less post-op nausea and vomiting^7-8 and the potential for increased operational efficiencies and significant reductions in LOS and readmissions.^4,6-10

For more information about the Titan SGS™ Stapler or to learn more about the Titan Sleeve™ Technique, visit standardbariatrics.com. Learn about the exciting innovation behind the Titan SGS™ Stapler at: Innovation Story.

About Teleflex
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.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, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, Titan SGS, Titan Sleeve, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

Dr. Morton and Dr. Ringold, two of the authors of the study, are paid consultants of Teleflex Incorporated.

*The Titan SGS™ Stapler is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation. The Titan SGS™ Stapler is one of several instruments used by surgeons during sleeve gastrectomy procedures and has been cleared by FDA based on clinical studies and other data establishing its performance for this purpose. The Titan SGS™ Stapler is not indicated for weight loss.

© 2025 Teleflex Incorporated. All rights reserved. MC-010771

References

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¹Ying L, Rutledge R, Butensky S, et al. Does stapling platform influence robotic sleeve gastrectomy postoperative outcomes?. Obes Surg. 2025; doi: 10.1007/s11695-025-07855-z.
² Angrisani L, Santonicola A, Iovino P, et al. Bariatric Surgery Worldwide 2013. Obes Surg. 2015;25:1822–1832. doi: 10.1007/s11695-015-1657-z.
³ Masood M, Low DE, Deal SB, Kozarek RA. Current management and treatment paradigms of gastroesophageal reflux disease following sleeve gastrectomy. J Clin Med. 2024;13(5):1246. doi: 10.3390/jcm13051246
⁴ Thompson J, Dhar V, Hanseman D, et al. Anatomy-based laparoscopic sleeve gastrectomy reduces gastroesophageal reflux disease compared to laparoscopic sleeve gastrectomy with bougie. Surgery for Obesity and Related Diseases, 2017;13(10). doi: 10.1016/j.soard.2017.09.242.
⁵ Toro, J., Lin, E., Patel, A., et al. Association of Radiographic Morphology with Early Gastroesophageal Reflux Disease and Satiety Control after Sleeve Gastrectomy. Journal of the American College of Surgeons, 2014;219(3), 430–438. doi: 10.1016/j.jamcollsurg.2014.02.036
⁶ U.S. Food and Drug Administration. 510(k) Premarket Notification: K210278. Published April 28, 2021.
⁷ Standard Bariatrics, Inc. Multisite comparison of Titan SGS to existing surgical staplers in sleeve gastrectomy; 2022. Qualitee 360 Report. Unpublished raw data. Retrieved from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database.
⁸ Fritz GD, Sharrak A, Aubrey J, et al. Perioperative outcomes using single-fire stapler. Obes Surg. 2024;34(9):3553-3560. doi:10.1007/s11695-024-07357-4.
⁹ Salyer CE, Thompson J, Hoffman A, et al. (2022). Multisite Study of Titan SGS Stapler in longitudinal gastric resection. Surg Endosc. 2021;35(7):4016-4021. doi:10.1007/s00464-020-07858-0.
¹⁰ Varban OA, Niemann A, Stricklen A, et al. Far from Standardized: Using Surgical Videos to Identify Variation in Technique for Laparoscopic Sleeve Gastrectomy. J Laparoendosc Adv Surg Tech A.2017;27(8):761–767. doi:10.1089/lap.2017.0184.

Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610-948-2836

FAQ

What are the GERD reduction rates for Teleflex's (TFX) Titan SGS™ Stapler compared to traditional staplers?

The study showed Titan SGS™ Stapler achieved 7.1% GERD rates compared to 26.4% with multi-fire staplers, and 1.8% de novo GERD rates versus 10.9% with traditional staplers.

How does the Titan SGS™ Stapler's weight loss effectiveness compare to traditional multi-fire staplers?

The study showed equivalent weight loss outcomes at 1 year between Titan SGS™ (22.0% ± 1.7%) and multi-fire staplers (22.4% ± 0.7%).

What makes Teleflex's Titan SGS™ Stapler unique in sleeve gastrectomy procedures?

It is the first and only single-fire surgical stapler specifically designed for sleeve gastrectomy, featuring a 23cm continuous staple line that creates consistent tubular sleeve anatomy.

How many patients were included in the Teleflex Titan SGS™ Stapler study?

The retrospective study comprised 257 patients who underwent robot-assisted sleeve gastrectomy between 2016 and 2023.

What is the GERD resolution rate for patients using the Titan SGS™ Stapler?

The study showed a 25% GERD resolution rate in the Titan SGS™ cohort compared to 10.9% in the multi-fire cohort.