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USGI medical tissue anchors show durability beyond 1 year
Date:9/13/2010

o have used the IOP to close stomach incisions after removing the gall bladder through the stomach/mouth in NOTES (Natural Orifice Translumenal Endoscopic Surgery) cholecystectomy operations.

To perform these procedures, surgeons pass the flexible USGI IOP down a patient's throat and use these tools to grasp tissue and deploy the Expandable Tissue Anchors to create desired tissue folds that re-shape the stomach or close incisions in the stomach. An endoscope provides visualization during the procedures.

Of the patients who had ROSE for dilated pouch and stoma repair, data presented showed that 92% of those who underwent 12-month endoscopies (N=66) still had visible anchors and tissue folds. The tissue anchors were all visible during 18-month follow-up endoscopies in both patients who underwent ROSE to repair a slipped Nissen and all three patients who had six-month follow-up endoscopies after ROSE for gastro-gastric fistula repair.

Similarly, tissue anchors were visible during 24-month follow-up endoscopies in all five of the patients who had NOTES cholecystectomies. No serious adverse events, ulcerations, or strictures were reported.

The devices that make up the IOP have 510(k) clearance in the U.S. for tissue approximation in minimally invasive GI procedures and also received the European CE Mark in March 2010. USGI markets the IOP to surgeons in the U.S. and works closely with its distribution partners to build Incisionless Surgery Centers worldwide.


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Contact: Hollister H. Hovey
hhovey@lazarpartners.com
212-867-1762
USGI
Source:Eurekalert

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