Medical Devices: Evidence and Research (Dec 2023)
A Comparison of the Preclinical Performance of the Echelon™+ Stapler with Thunderbird Reloads to Two Commercial Endoscopic Surgical Staplers
Abstract
Shanshan Wang, Ying Hua, Jun Liu, Zhifan F Huang, Jeffrey W Clymer, Crystal D Ricketts, Jin Hao Ethicon, Inc, Cincinnati, OH, USACorrespondence: Jeffrey W Clymer, Ethicon, Inc, 4545 Creek Road, Cincinnati, OH, 45242, USA, Email [email protected]: Design of surgical staplers continues to advance with more consistent staple formation that can lead to higher leak pressures and lower rates of leak along the staple line. This study was performed to compare the Ethicon Echelon™+ Stapler with Thunderbird reloads to two other currently available commercial staplers, Reach Anzhi and Fulbright Lunar with corresponding reloads.Methods: The rate of malformed staples for three staplers was determined in porcine stomach (3.0– 3.3 mm thickness) via CT scanning. Staple line air leak pressures in bronchial tissue (3.0– 3.3 mm) and fluid leak pressures in colon (1.3– 1.7 mm) were measured and compared to a standard success criterion for both tissues.Results: The rate of malformed staples in gastric tissue for Echelon+ was more than 90% lower than for the two other commercial staplers (p < 0.001). In bronchus, Echelon+ had 56% higher air leak pressures than Reach Anzhi (p < 0.001) and was not significantly different from Fulbright Lunar. In colon, Echelon+ had over twice the fluid leak pressures of the comparators (p < 0.001).Conclusion: The Echelon+ Stapler with Thunderbird reloads exhibited a low rate of malformed staples, and its staple lines withstood high leak pressures in both thick and thin tissues. Clinical studies are needed to confirm that these observed benefits carry over into actual practice.Keywords: stapler, endoscopic, burst pressure, malformed staples, leaking