Thank you for being a loyal customer of Hologic and the NovaSure® Endometrial Ablation System
The NovaSure Endometrial Ablation System is the Gynecologists’ preferred choice for treating menorrhagia. The success of the NovaSure procedure has helped to reduce the number of unnecessary hysterectomies and has redefined the standard for safety, procedural efficiency, and improved patient outcomes.
As part of our commitment to you, we are continually working on product upgrades and enhancements to maintain the NovaSure Endometrial Ablation System as the market leader. One such enhancement has been made to the disposable device and the corresponding Instructions for Use manual.
Removal of Luer Locks:
To streamline the NovaSure disposable device assembly process we have removed the luer fittings from the suction line to make it one continuous line and we have modified the luer fittings on the vacuum feedback line to a double barbed filter connection; please see figures 1 & 2 below. These modifications to the tubing do not require any change in the way you perform the procedure. You will notice these changes beginning April 2013 for Combo Kits (NS2007US) and May 2013 for 3-packs (NS2000US).
We have updated the Instructions for Use manual and troubleshooting guide where appropriate. Should you need assistance during a case you can always contact your local Hologic Sales Representative and/or the Hologic Tech Services team at (800) 442-9892, option 1#.
Additional IFU Update:
In an effort to reinforce consistency in the procedure steps we would also like to draw your attention to an update in the NovaSure disposable device seating, as noted, in the steps of the procedure.
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| In procedure step 2.27 (in the Instructions for Use manual), we have replaced: |
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Maintain a reference point at the fundus. Slowly squeeze the handles (DO NOT LOCK) up to the point of increased resistance. DO NOT pull the device back from the fundus. |
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Withdraw the device from the fundus by approximately 0.5 cm. Slowly squeeze the handles (DO NOT LOCK) up to the point of increased resistance. |
| See new image to accompany this step in the Instructions for Use manual pictured below: |
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As with all NovaSure disposable device seating and procedure steps, these should be performed slowly and gently.
Please work with your Hologic Sales Representative to review the steps of the procedure and seating requirements as needed.
At Hologic we value our customers and your patients. We sincerely appreciate your support. Should you have any questions regarding these device modifications please contact your local Hologic Sales Representative.
Sincerely,
Natalie MacMillan
NovaSure Associate Product Manager |
