[0:12]Remove the needle driver handle from its packaging and lay next to the endoscope on a flat surface, with the scope tip and end cap pointed toward your dominant hand. Insert scope insertion tube behind handle and Into open c-shaped slot of needle Driver Handle Collar. Slide handle up endoscope until fully seated. Ensure channel ports are aligned under the scope knobs. Secure by stretching the blue rubber handle strap around the rear of endoscope over the top of endoscope channel port and fitting back onto attachment peg. Close the handle. With scope channel oriented toward inside of Endcap, insert the distal end of scope at a 45 degree angle into the middle of the Endcap Adapter, and push scope forward until it is fully seated against the roof of the Endcap Adapter. Rotate to align scope channel with white alignment dot. With non-dominant hand, secure the scope position by pinching the scope and Endcap. Using your dominant hand and Tape Wand, place Tape eyelet hole over distal hook of Endcap Adapter. Wrap tape around scope, maintaining high tension until the tape has been fully applied. Repeat for the second Tape Wand on Endcap Adapter's proximal Hook. Working distal to proximal, remove white backing from sheath tape and wrap each sheath tape securely around both scope and sheath. Repeat for all three sheath tapes. Remove Suture Assembly and Anchor Exchange from packaging. Load the Anchor onto the Anchor Exchange. Remove Suture from Suture Cartridge by holding and pulling the Suture, not the Anchor or Anchor Exchange. With the Biopsy Cap open, Insert Anchor Exchange into the Anchor Exchange channel of the device. Advance Anchor Exchange catheter until the orange marker band is partially inside the channel port. This reference places the Anchor safely within the Endcap. Remove the Tissue Helix Pro from its packaging. Open the adjacent Biopsy Cap and advance the Tissue Helix Into the helix channel until orange depth marker band is at entry of Biopsy Cap or until distal tip is visible. To activate the MaxFlex Advanced Retroflexion, fully articulate the scope using the primary "Up" dial and hold the dial to maintain this position. Do not lock the scope wheel. Disengage Pull String Handle from underneath device Handle. Pull on Pull String straight out from device to increase articulation to desired position. Wrap Pull String around brake washer on side of device a minimum of two times to secure device position. To release, hold endoscope "Up" dial at its fully articulated position and then release Pull String by unwrapping from brake washer and letting go of tension in string. Secure Pull String back underneath device, ensuring string is not wrapped around handle. Release scope dial.
[3:07]Prepare to suture by loading the Anchor Exchange catheter and close the Needle Driver Handle. Using a pencil-grip on the white portion of the cable, advance the Anchor Exchange until Anchor fully seats onto Needle Body while pressing and holding the blue Anchor Release Button. Pull back approximately one centimeter to disengage the anchor from the needle body. Open the OverStitch NXT handle. Acquire tissue by advancing and rotating the Helix Catheter or Handle clockwise until desired tissue depth is achieved, while maintaining gentle forward pressure. To ensure a full thickness bite, maneuver the scope such that the tissue will be aligned to the right of the scope tower. Pull the Tissue Helix In, until the tissue is within the scope tower jaw. Close the Needle Driver Handle to advance the anchor through the tissue. Advance the Anchor Exchange Catheter over the anchor until locking mechanism engages. Without pressing the blue button, pull the anchor exchange back to disengage the anchor from the needle body. Turn the Tissue Helix counterclockwise to disengage the tissue. Finally, open the NXT handle to release the tissue. Pull scope back to create suture slack and prepare for the next suture bite. Repeat steps for additional suture bites. To prepare for cinching, extend the Anchor Exchange Catheter out past the Endcap. Press the blue button and pull back on the Anchor Exchange Catheter to release the anchor. Remove the Anchor Exchange Catheter from the device channel, leaving the suture in place. To load the cinch, thread approximately three centimeters of the distal end of the suture through the gold suture loading loop. Pull the gold tab down or In the line with the catheter until the suture has passed through the PEEK collar. While holding slight tension on the suture, insert the cinch into the working channel of the device. Advance the cinch catheter until it extends past the NXT Endcap, targeting the placement of the first bite. While holding the cinch catheter in place for countertraction, apply tension to the suture with small, increasing increments of force. Care should be taken not to pull the suture too tight, resulting in breakage. Once the desired amount of tension is reached, open the cinch handle with the palm facing down. This will release the safety mechanism. Stage one of cinching is to squeeze the cinch handle with one hand to pull the PEEK plug into the collar and lock the suture in the cinch. Stage two of deploying the cinch will require two hands. Continue to squeeze the cinch handle to advance the beaded rod through the PEEK plug. For the final stage, continue to squeeze the handle to activate the suture cutter and release the PEEK collar and plug. Remove the cinch and suture from the scope channel. To remove the NXT device, use a scalpel or scissor and slide the sharp edge behind the tape, working away from the scope tip. Unwrap the tape in the reverse direction of application, moving your hands towards the top of the scope channel. Pull the scope and the sheath apart to separate the device from the scope. To remove the NXT handle, pull the blue strap away from the scope to release and unwind from the scope. Once the blue strap is unhooked, pull the NXT handle back down the scope neck to remove.
