Covidien (NYSE:COV) said its Japanese branch secured regulatory approval for its Endo GIA surgical staple system.
The Japanese Ministry of Health, Labor & Welfare approved the Endo GIA Reinforced Reload with Tri-Staple technology to provide additional support to fragile tissue by delivering an advanced polymer felt material along with the staples. The device is expect to enter the Japanese market soon, according to a press release.
“This approval enables Covidien to offer an innovative technology that supports the company’s vision of improving patient outcomes and expanding global access to care. Integrating tissue stapling with buttress provides surgeons with both greater functionality and efficiency,” Covidien Japan president Ryo Noda said in prepared remarks.
This is good news for Covidien, which has seen its surgical staples business struggle. The company was investigated by the FDA due to the 2012 recall of its Duet TRS surgical staples, when the devices were associated with 13 patients injuries and 3 deaths. Covidien went on to discontinue the line later that year. In addition, the company had to warn hospitals in 2013 to watch out for a stolen lot of Endo GIA Articulating 60-3.5 Surgical Stapler Reloads, which were nabbed prior to undergoing sterilization.
