NMT II: Products

 

NobleStitch

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The NobleStitch allows physicians to place a single polypropylene suture in vascular and cardiovascular structures including through the septum secundum and septum primmum to form a proprietary “S” shaped suture closure of the PFO tunnel, which allows larger tunnels to be closed with a single suture. The sutures are then tied together using the proprietary “KwiKnot®” with integrated suture cutter. The NobleStitch is approved in Europe for vascular and cardiovascular suturing and PFO closure. In the United States the NobleStitch is FDA cleared and is indicated for use in the placement of sutures for soft tissue approximation in surgical procedures such as general, vascular, and cardiovascular surgery, including endoscopic procedures.  The NobleStitch EL is not indicated for blind closure.

The NobleStitch uses a 4-0 polypropylene suture which is introduced through the femoral vein over a 0.18 guide wire which is placed in the superior vena cava, and the second wire placed through the PFO tunnel. This is performed through a 14 French 75mm sheath.

The distal tip of the (secondary) catheter is advanced through the 14 French sheath into the SVC. The suture-carrying arm is then opened by pressing Button #1 under fluoroscopic visualization. The sheath is advanced to the open arm, drawing the arm to the 0.32 wire in the PFO tunnel. The sheath and secondary NobleStitch are advanced to the septum secundum, positioning is verified under fluoroscopic visualization.

The needles are then drawn through the septum secundum using the syringe style handle to capture the suture, and then draw it back through the septum secundum. The sheath and NobleStitch are withdrawn away from the secundum septum approximately 1cm. The arm is closed by pressing button #3, and the NobleStitch, and 0.18 guide wire are gently withdrawn from the sheath, where the sutures are detached for later use.

The NobleStitch primary device is then advanced through the 14 French sheath over the 0.32 guide wire into the PFO. (NOTE: no need to place the sheath through the PFO) Button #1 is then pressed, opening the suture carrying arm. The NobleStitch is withdrawn against the septum premum. Verification by fluoro is performed. The needle is advanced through the primum to capture the suture, and retrieve. The NobleStitch is advanced forward over the wire, allowing clearance by pressing button #3. The NobleStitch, and the 0.32 wire are withdrawn through the sheath to allow the sutures to be attached, and drawn into place. The sutures are then loaded through the KwiKnot which is advanced through the sheath over the sutures to the septum. By pressing button #1, the knot is deployed under fluoroscopic visualization. Then, button #2 is rotated to cut the sutures, and the sheath and KwiKnot are removed.

Animation and live case using the NobleStitch PFO closure device.

Benefits of the NobleStitch design include:

  • NO “DEVICE” IMPLANTED
  •  No metal or foreign body left behind (only polypropylene suture)
  •  No risk of nickel allergy reaction
  •  No risk of device migration
  •  No risk of device erosion
  •  No device to encapsulate thrombus, eliminating the associated risk of thrombogenic related strokes from an implanted device
  • Does not inhibit future trans-septal procedures
  • Does not require ultrasonic guidance
  • Does not require anticoagulation or other medical therapy

Cases

Dr. Mullen has performed the most cases of any physician using the NobleStitch device, with an unmatched success rate. This video features informative animation indicating the steps taken using the NobleStitch EL PFO closure device during a case completed by Dr. Mullen.

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KwiKnot®

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The KwiKnot® is an accessory to the NobleStitch. After using the NobleStitch, the KwiKnot® can be used to advance a “knot” to the suturing site as well as cut it.

Benefits of the KwiKnot® design are:
– Polypropylene knot
– Radio opaque
– Simple to use
– No need for manual knot tying
– Integrated suture cutter

 

 

The NobleStitch is approved in Europe for vascular and cardiovascular suturing and PFO closure. In the United States the NobleStitch is FDA cleared and is indicated for use in the placement of sutures for soft tissue approximation in surgical procedures such as general, vascular and cardiovascular surgery, including endoscopic procedures at the end of that last sentence add The NobleStitch EL is not indicated for blind closure.

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