45mm Ethicon Echelon Flex GST System gains 510(k) clearance

Departments - FDA, mergers, & funding

The Echelon Flex GST System now offers 45mm and 60mm endocutters with exclusive reloads.

March 31, 2017

Ethicon’s Echelon Flex GST System (45mm) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). With this addition, the Echelon Flex GST System now offers 45mm and 60mm endocutters with exclusive reloads.

“The Echelon Flex GST System controls tissue movement with pre-compression and gripping surface technology, which is 7x more likely to completely capture mucosa in the staple line versus the other leading endocutter on the market, optimizing tissue for healing,” says Tom O’Brien, vice president, global endomechanical platform leader.

The importance of endocutters continues to grow as more complex surgeries are being performed through minimally invasive approaches. The Echelon Flex GST System controls tissue movement to ensure surgeons transect exactly as intended, which is especially important when dealing with challenging tissue. The Echelon Flex GST System (45mm) offers performance improvements for several specialties including thoracic, colorectal, and bariatric. www.ethicon.com; www.jnj.com

FDA 510(K), Canadian license for image guidance system

7D Surgical received U.S. Food and Drug Administration (FDA) 510(k) clearance and a medical device license (MDL) from Health Canada, enabling the commercial North American launch of its Machine-vision Image Guided Surgery (MIGS) spinal surgery system.

MIGS employs 3D optical technologies and machine vision algorithms to eliminate barriers to adoption of existing surgical navigational platforms. Unlike conventional image guided surgery (IGS) systems that depend on intraoperative radiation – it can register spinal surgery patients using only visible light – achieving fast surgical workflow for spine procedures.

MIGS navigation technology is embedded in an onboard overhead surgical light, eliminating line-of-sight frustrations in the operating room. The surgeon controls the software using a foot pedal. www.7Dsurgical.com