Hologic NovaSure Endometrial Ablation Device Kit
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The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in-date item only.
Description
Hologic NovaSure Endometrial Ablation
The unique, radiofrequency impedance-based technology available with the Hologic NovaSure system customizes patient results, delivering:
- Quick and controlled bipolar radiofrequency (RF) energy — a proven ablation modality in many surgical specialties.
- A customized ablation when the scientific endpoint of 50 ohms of impedance or 2 minutes is reached.
- Individual cavity measurements for each patient, enabling you to tailor the treatment to the specific patient.
- The only system with a proprietary proactive safety check prior to the procedure to assess cavity integrity; insufflating the cavity using CO2, the system can detect pressure leaks to confirm uterine cavity integrity.
- A unique moisture transport system, which ensures tissue contact with the array and removes steam, blood and other byproducts; removal of steam during the procedure is essential to maintaining a controlled ablation.
- Treatment regardless of a patient's cycle and without any pretreatment required.
Additional information
| Size | 1 |
|---|---|
| Arms | N/A |
| Manufacturer | |
| Unit | box of 1 |
- FDA Product Code: MNB
- FDA Product Code Name: Device, Thermal Ablation, Endometrial
- GMDN Term Code: 66632
- GMDN Term Name: Radio-frequency endometrial-ablation system handpiece/electrode
- GMDN Term Description: A combined handpiece and bipolar electrode array intended to be introduced into the uterine cavity to deliver radio-frequency (RF) current for coagulation/ablation of the endometrium to treat menorrhagia. It is designed to be inserted without imaging whereby the electrode array is expanded in situ to achieve full endometrium contact. It includes tubing for delivery of carbon dioxide (CO2) to assess uterine cavity integrity (intactness), and for suction to clear and maintain endometrium contact within the cavity; ablation is automatically interrupted at a pre-set impedance threshold. This is a single-use device.
