Ethicon Announces 510(k) Clearance For ECHELON CIRCULAR™ Powered Stapler
Apr 19, 2017, 09:00 ET
CINCINNATI, April 19, 2017 /PRNewswire/ -- 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 leading global provider of medical devices, announced today 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," says 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"
About Ethicon
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treating serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.
* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon Endo-Surgery, Inc. is the legal manufacturer of ECHELON CIRCULAR™ Powered Staplers.
- Benchtop 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.
- Benchtop testing on porcine colon, comparing Ethicon CDH29P to Medtronic EEA2835, p<0.001.
- Staple line analysis in benchtop testing, comparing Ethicon CDH25P to Medtronic EEA2835.
SOURCE Ethicon