AUTOMATIC SUTURING AND LIGATING DEVICE technology forms a completed stitch of absorbable or nonabsorbable polymer monofilament in second, even in areas of limited access such as laparoscopic surgery. Suture is threaded through tissue, tensioned, cut to length and welded in place using a proprietary process. This research seeks to demonstrate the feasibility of suturing using this device and method and establish its equivalency to knotted sutures. This will be accomplished by building a development prototype device, mechanical testing of sutures formed by the device to the requirements of USP XXIII and other standards, and a histological examination of the effects of the suturing process in both acute and chronic studies in an animal model. Proving equivalency to conventional sutures is a vital step toward development of a procedure-specific commercial product to be developed in Phase II.
