FDA Clears Ethicon’s ECHELON CIRCULAR Powered Stapler

The circular anastomosis is one of the most critical steps in cancer surgery and has a high risk for complications. Complications can include leaks and bleeding which can require reoperation. In an effort to make measurable clinical and cost-of-care improvements for healthcare providers and patients globally, Ethicon, a global provider of medical devices, announced that the ECHELON CIRCULAR Powered Stapler has received 510(k) clearance from the U.S. Food and Drug Administration. The ECHELON CIRCULAR Powered Stapler was designed to reduce anastomotic complications in colorectal, gastric, and thoracic cancer surgeries.
 
Only the ECHELON CIRCULAR Powered Stapler provides two new technologies to reduce leaks without compromising perfusion—resulting in 61% fewer leaks at the staple line compared to Medtronic’s DST Series EEA Stapler.¹ Gripping Surface Technology provides gentler handling with a 33% reduction in compressive forces on tissue², and 3D Stapling Technology evenly distributes compression throughout the anastomosis.³ These two technologies work together to consistently optimize perfusion and reduce leaks at the staple line.¹
 
“Ethicon is committed to reducing complications, which have a significant impact on healthcare costs and patient outcomes,” said Tom O’Brien, vice president, global endomechanical platform leader. “The ECHELON CIRCULAR Powered Stapler addresses these challenges by combining powered firing with two staple forming innovations that reduce leaks without compromising perfusion.¹“
 
References
¹Benchtop testing in porcine tissue ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic EEA2835 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices.
²Benchtop testing on porcine colon, comparing Ethicon CDH29P to Medtronic EEA2835, p<0.001.
³Staple line analysis in benchtop testing, comparing Ethicon CDH25P to Medtronic EEA2835.