Covidien Receives Japanese Regulatory Approval for Reinforced Stapling Reload Technology
Covidien plc has announced that its Japanese subsidiary, Covidien Japan Inc., has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Endo GIA™ Reinforced Reload with Tri-Staple™ technology. This approval extends Covidien’s industry-leading portfolio of advanced surgical staplers and represents a return by the company to the Japanese stapling buttress market.
The newly approved Endo GIA Reinforced Reload will enable surgeons to deliver an advanced polymer felt material to provide additional support to fragile tissues when deploying Covidien’s Tri-Staple™ surgical stapling technology. The buttressing material itself is a version of NEOVEIL® felt, developed by GUNZE Ltd., which has been validated clinically in the Japanese market for more than 20 years.
“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,” said Ryo Noda, president, Covidien Japan. “Integrating tissue stapling with buttress provides surgeons with both greater functionality and efficiency.” Covidien expects to begin offering Endo GIA Reinforced Reload with Tri-Staple Technology in the Japanese market in the coming months.