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The TroClose1200™ bladeless trocar is intended for use in a variety of gynecologic, general and urologic endoscopic procedures to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic/laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions.

The TroClose1200™ is a Trocar system comprised of an Obturator and a Cannula including pre-loaded sutures. It includes a bladeless Obturator, designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two absorbable PGLA sutures, each attached to an absorbable PLGA anchor. The deployment of the anchors and sutures ("closure device") is achieved by utilizing two pushers within the Obturator as a deployment mechanism.

The TroClose1200™, as one unit, consists of the following components:

• An Obturator, which is the part of a trocar that allows the insertion of the trocar (after routine scalpel-made incision). An Obturator is for single patient use. For this purpose, the Company's Obturator is bladeless, similar to the predicate Obturator. In addition, the Company's Obturator has a set of 2 pushers that deploy the anchors with sutures attached from the Cannula for later closure.
• A Cannula, which is the part of a trocar that establishes the working channel through which the surgeon introduces surgical tools while keeping the CO2 in the abdominal lumen. The Cannula is for single use and is similar to the predicate trocar Cannula. In addition, the Company's Cannula has 2 absorbable anchors attached to absorbable sutures, at 180º to each other, as the closure device, which is similar to the predicate closure device. The suture (thread) is made of absorbable PLGA and the anchors are made of absorbable PLGA and are designed to close the access port by suturing the abdominal wall's fascia.

GORDIAN's TroClose1200™ is manufactured from routinely used medical device biocompatible materials. Like its predicates, this device is provided sterile (by EtO) and intended for single patient (Obturator) and single use (Cannula) only.

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