Device Dossier
Tri-Staple™ 2.0 Curved Tip Intelligent Reload - Surgical staple, non-bioabsorbable
Device Dossier for Tri-Staple™ 2.0 Curved Tip Intelligent Reload - Surgical staple, non-bioabsorbable (Surgical staple, non-bioabsorbable, Class III,…
- GMDN category: Surgical staple, non-bioabsorbable
Intended purpose
Tri-Staple™ 2.0 reinforced reload preloaded with polyglycolic acid staple line reinforcement is indicated for use in abdominal and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. The intended purpose of the device is transection and resection of tissue, and/or creation of anastomosis.
Functional description
A triple-staggered row of titanium staples and 2 layers of non-woven absorbable PGA mesh reinforcement material are placed on either side of the cut line. The tissue and staple line reinforcement material are divided on deployment of the staples. The PGA mesh (secured to the reload with Maxon absorbable suture) acts as staple line reinforcement and is deployed upon reload firing and transection, attaching the reinforcement material to the rows of staples.