Teleflex
(NYSE: TFX)
today announced data from a retrospective analysis linking its Titan SGS stapler to enhanced outcomes.
Wayne, Pennsylvania-based Teleflex said the data demonstrated improved clinical outcomes and significant procedural efficiency benefits. The analysis compared the Titan SGS stapler to multi-fire surgical staplers in patients undergoing laparoscopic sleeve gastrectomy (LSG).
Five surgeons at a Corewell Health Hospital in Grand Rapids, Michigan, conducted the study. They published their findings in the journal Obesity Surgery.
Titan SGS 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, according to a news release. Teleflex acquired the stapler through its 2022 purchase of Standard Bariatrics.
The anatomy-based approach of surgical stapling helps surgeons achieve more consistent and symmetrical anatomy with Titan SGS. It features a 23 cm continuous staple line to allow surgeons to plan and place staples in one firing. The stapler eliminates the risk of overlapping staple lines, a known risk factor for leaks.
Teleflex reported results from 807 patients who underwent LSG using the second-generation SGS stapler. It compared them to 3,829 patients who underwent LSG using multi-fire staplers.
The company reported a median operative time for Titan that came in eight minutes shorter than the multi-fire staplers. Patients also proved more likely to get discharged within 24 hours of surgery with Titan SGS (89.6%) compared to multi-fire (65%).
Over 30 days, Titan SGS led to fewer readmissions, especially related to nausea and vomiting (1.7% vs. 4.5%). Teleflex also reported a trend toward a reduction in reoperations and leaks by 30 days. Investigators saw a similar rate of post-operative bleeds as well. The study showed no leaks, strictures or post-operative interventions in the Titan SGS cohort.
Investigators note that weight loss at six months was slightly, yet significantly greater in the multi-fire group. However, they say preliminary review of the one-year data showed that this difference diminishes. The authors concluded that “the simplified and efficient stapling process offered by [Titan SGS] has the potential to enhance the safety and effectiveness of LSG, ultimately benefiting patients and healthcare providers.”
“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 GM, Surgical, at Teleflex.
