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sojourner

11/21/07 1:43 PM

#13683 RE: vany #13681

vany: Worthy question, but it's very difficult to see how LTC is not "substantially equivalent" (albeit a vast improvement) to existing electro-surgical technology. LTC does the same thing the Ethicon gadget does. However, unlike Ethicon's FDA 510(k) approved device, Live Tissue Connect doesn't char or sear the tissue or organ, preserves live healthy tissue, and affords higher surgical burst strength. Hence, SE would be a rational designation.

(Not to mention LTC introduces no foreign matter into the body, minimizing infection, and cuts surgery and post-op recovery time in half.)