Teleflex Announces Publication of a Propensity Matching Review of Retrospective Data Reporting that the Titan SGS™ Stapler Enables Consistent Gastric Pouch Formation with Fewer Variations, Providing Potentially Enhanced Clinical Outcomes and Significant Procedural Efficiency Compared with Traditional Surgical Staplers
- Retrospective data from the largest comparative case series of patients undergoing laparoscopic sleeve gastrectomy (LSG) with the Titan SGS™ Stapler echo previously reported reductions in length of hospital stay, readmission, and operative time
- Study conducted at a site accredited by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), assuring data quality, reliability and consistency
WAYNE, Pa., Aug. 21, 2024 (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 linking the Titan SGS™ Stapler with enhanced clinical outcomes and significant procedural efficiency benefits compared with multi-fire surgical staplers in patients undergoing laparoscopic sleeve gastrectomy (LSG).1 The study was conducted by five surgeons at a Corewell Health Hospital in Grand Rapids, MI, an MBSAQIP-accredited facility that is a Center of Excellence for bariatric surgery.* The study results appear in the current issue of Obesity Surgery.1
"LSG is a validated yet underutilized approach to the long-term management of obesity," said Jon L. Schram, MD, FACS, Section Chief and Medical Director, Bariatric Surgery, Corewell Health, and an author on the publication. "In my experience, patients' concerns about adverse events, hospital length of stay, and the potential need for readmission or secondary surgery are barriers to more widespread use of LSG. Our study may help allay many of those concerns, as it shows that use of the Titan SGS™ Stapler's simplified and efficient stapling process was associated with less nausea and vomiting, fewer 30-day readmissions, and a greater likelihood of discharge within 24 hours after surgery compared with multi-fire staplers."
The Titan SGS™ Stapler is the first and only single-fire, surgical stapler designed and indicated for sleeve gastrectomy pouch creation and the only surgical stapler cleared by the FDA for this specific indication.2 As the only stapler to provide a 23cm staple line — the industry's longest continuous staple cutline —the Titan SGS™ Stapler eliminates the risk of overlapping staple lines,3,4 which is a known risk factor for leaks.5 The FDA recommends labeling of staplers to include "risks specifically associated with the crossing of staple lines"5 and published a concurrent letter to healthcare providers6 with the labeling guidance for the medical device industry clarifying this risk.
- The publication reports retrospective observational data from the largest comparative case series of the Titan SGS™ Stapler in sleeve gastrectomy to date and includes 807 patients who underwent LSG using the second-generation Titan SGS™ Stapler and 3,829 patients who underwent LSG using multi-fire staplers. The data were collected from procedures performed by five experienced surgeons at a single institution between November 2022 and January 2024 (Titan SGS™ Stapler procedures) and September 2016 to September 2021 (multi-fire stapler procedures).1 The study data were obtained from the MBSAQIP database and included outcomes through one year following LSG. A propensity matching approach was undertaken to account for significant differences in predictive factors between the two study cohorts. This resulted in 783 patients in each cohort. As a single-site study, the surgical approach within each cohort was similar. One notable difference is that no buttressing material was used in any of the procedures performed with the Titan SGS™ Stapler, while buttressing material was used for every multi-fire staple firing.
Key outcomes from the study include:
- Improved procedural efficiency1
- Median operative time for the Titan SGS™ Stapler was 8 minutes less than multi-fire staplers (p<0.01).
- Patients were more likely to be discharged within 24 hours of surgery when LSG was performed using the Titan SGS™ Stapler (702, 89.6%) as compared with multi-fire staplers (509, 65.0%).
- Short-term (30-day) outcomes1
- There were fewer 30-day readmissions, especially those related to nausea and vomiting, in the Titan SGS™ Stapler cohort (13, 1.7%) compared with the multi-fire cohort (35, 4.5%) (p<0.01).
- There was a trend toward a reduction in reoperations (3, 0.4%) and leaks by 30-days (0, 0.0%) in the Titan SGS™ Stapler cohort compared with multi-fire cohort (8, 1.0% and 4, 0.5%, respectively) but this trend did not reach statistical significance (p=0.13 and p<0.02, respectively).
- The rate of post-operative bleeds within 72 hours was similar between the Titan SGS™ Stapler (5, 0.6%) and multi-fire cohorts (4, 0.5%) (p=0.74).
- There were no leaks, strictures, or post-operative interventions reported in the Titan SGS™ Stapler cohort.
- No post-operative port site hernias, or instrument misfires, or malfunctions have been encountered to date in the Titan SGS™ Stapler cohort.
- 6- and 12-month outcomes1
- The study authors note that "Weight loss at 6 months was slightly yet significantly greater in the sequential fire group… preliminary review of the 1-year data shows that this difference diminishes."**
- The study authors note that "Weight loss at 6 months was slightly yet significantly greater in the sequential fire group… preliminary review of the 1-year data shows that this difference diminishes."**
The study authors conclude that "the simplified and efficient stapling process offered by [the Titan SGS™ Stapler] has the potential to enhance the safety and effectiveness of LSG, ultimately benefiting patients and healthcare providers."1
"Based on the real-world evidence from this and other studies completed to date, patients and surgeons can be confident in the use of this first and only stapler specifically designed for sleeve gastrectomy pouch creation," said James Ferguson, President and General Manager, Surgical, at Teleflex.
Additional retrospective analyses of data from LSG procedures performed using the Titan SGS™ Stapler compared with multi-fire staplers are ongoing, and the results of these studies are expected to be published in the future.
For more information about the Titan SGS™ Stapler or to learn more about the Standard Sleeve™ Technique, visit standardbariatrics.com. Learn about the exciting innovation behind the Titan SGS™ Stapler at: Innovation Story.
About Teleflex Incorporated
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, Deknatel, LMA, Pilling, QuikClot, Titan SGS, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2024 Teleflex Incorporated. All rights reserved. MC-009962.
Dr. Schram and Dr. Foote, two of the authors of the study, are paid consultants of Teleflex Incorporated.
* MBSAQIP accreditation requires an independent, voluntary, and rigorous peer evaluation in accordance with nationally recognized bariatric surgical standards, as well as reporting of standardized bariatric surgery outcomes to the MBSAQIP database.
** 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.
References:
1. Fritz, G.D., Sharrak, A., Aubrey, J., Topalli, X., Vrana, A., Opalikihn, A., Zambito, G.M., Martin, T.D., Foote, J.A., Smith, J.R., & Schram, J.L. (2024). Perioperative outcomes using single-fire stapler. Obesity Surgery(2024). https://doi.org/10.1007/s11695-024-07357-4
2. 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.
3. Salyer, C. E., Thompson, J., Hoffman, A., Burstein, M. D., Enochs, P., Watkins, B. M., Kuethe, J., & Goodman, M. D. (2022). Multisite Study of Titan SGS Stapler in longitudinal gastric resection. Surgical Endoscopy. https://doi.org/10.1007/s00464-022-09051-x
4. Salyer, C., Spuzzillo, A., Wakefield, D., Gomaa, D., Thompson, J., & Goodman, M. (2020 July). Assessment of a novel stapler performance for laparoscopic sleeve gastrectomy. Surgical Endoscopy, 35(7), 4016–4021. https://doi.org/10.1007/s00464-020-07858-0
5. U.S. Food and Drug Administration Center. (2021, Oct. 8). Surgical Staplers and Staples for Internal Use – Labeling Recommendations. (Docket No. FDA-2019-D-1262). Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surgical-staplers-and-staples-internal-use-labeling-recommendations
6. US Food and Drug Administration. (2021, October 7). UPDATE: Safe use of surgical staplers and staples–letter to health care providers. https://public4.pagefreezer.com/content/FDA/21-02-2024T12:58/https://www.fda.gov/medical-devices/letters-health-care-providers/update-safe-use-surgical-staplers-and-staples-letter-health-care-providers
Contacts:
Teleflex
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
[email protected]
610-948-2836
