The FDA has granted 510(k) clearance for Covidien’s Endo GIA Reinforced Reload with Tri-Staple technology, the only endoscopic stapler featuring preloaded tissue reinforcement, the Dublin, Ireland devicemaker says.
The Endo GIA stapler combines Tri-Staple technology with a preattached synthetic, porous buttress material that adds support to tissue. Covidien claims the radial reload allows surgeons to reach lower and up to 2 cm deeper into the pelvis than Ethicon’s Contour stapling technology. It also lets surgeons achieve greater distal margins, the company says, adding the Tri-Staple technology offers consistent hemostatic performance across various tissue thicknesses.
The Endo GIA system has progressive staple heights, 36-degree rotation, can operate in both coronal and sagittal planes and is compatible with all Endo GIA universal, Endo GIA Ultra Universal and iDrive ultra powered handles, according to Covidien.
Japan’s Pharmaceutical and Medical Devices Agency granted marketing authorization for the Endo GIA stapler last month, and Covidien expects to roll it out in both countries in the next few months. — Lena Freund
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