FAQs

NovaSure® Endometrial Ablation

Q. What methods of purchase are available for the NovaSure Endometrial Ablation Products?

A. We accept phone orders, faxed orders and credit card orders. An order confirmation is provided for all orders on the same day the order is placed.

Q. What is Hologic’s policy for returning unused product?

A. There is a 20% re-stocking/handling fee for all returned product. Because we sell all disposable devices in packages of 3, a complete 3-pack must be returned. We do not accept returns for single devices. All returns must be authorized with an RMA# issued by CSP. To obtain an RMA#, call Customer Service at 1.800.442.9892.

Q. What physicians are trained in the NovaSure procedure in my area?

A. We have a complete NovaSure physician user database for the entire United States and can provide you a list of trained physicians in your area. Call 1.800.442.9892 for a NovaSure physician in your area.

Q. How can I order more NovaSure Patient materials?

A. Additional NovaSure marketing materials are available by calling: 1.800.442.9892 or visiting gynmarketing.com.

Q. What is the shelf life of the NovaSure Disposable device?

A. The disposable device shelf life is at least 19 months from date of manufacturing. It is Hologic’s policy that NovaSure disposable devices shall be shipped with a minimum of three month’s shelf life remaining. All NovaSure 3 packs are labeled with a “Use Before” date for easy identification. It is important that devices are not used beyond their expiration date.

Q. What is the shelf life of the NovaSure Advanced device?

A. The Advanced device shelf life is at least 25 months from date of manufacturing. It is Hologic’s policy that NovaSure Advanced devices shall be shipped with a minimum of three month’s shelf life remaining. All NovaSure 3 packs are labeled with a “Use Before” date for easy identification. It is important that devices are not used beyond their expiration date.

Q. Is the NovaSure Disposable Device latex free?

A. Yes, the NovaSure disposable device is latex-free.

Q. Can the NovaSure disposable device be resterlized?

A. The disposable device is a single-use product that is provided sterile to the end user. Re-sterilization of the device should not be attempted for any reason.

Q. What if I have a disposable device to return that has been opened or used? Is there a process to return of the disposable device?

A. For Customers within the United States, please call us at 1.800.442.9892 for a Return Material Authorization. Your return request will be processed, and you will be issued an RMA# for this type of return. In addition, we will ship a biohazard kit for you to ship the used product back to Hologic for sterilization and evaluation.

Q. What is the life expectancy of the NovaSure controller?

A. The RF Controller was designed for a minimum of 5 years of useful life.

Q. What preventive maintenance and care are required for the NovaSure RF controller?

A. No maintenance is necessary other than regular cleanings, as described in the operator’s manual.

MyoSure® Tissue Removal System

Q. What is the MyoSure Procedure?

A. The MyoSure Tissue Removal System is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas and endometrial polyps. Learn More

Q. What happens during the MyoSure procedure?

A. The MyoSure procedure is a quick and simple way to remove and resect uterine tissue. In addition, it can be performed in a hospital setting or in your office. Watch Video

Q. Can the MyoSure system remove large fibroids?

A. Yes. With the MyoSure XL device, the MyoSure system is designed to remove a 5 cm fibroid in 15 minutes or less of cutting time.

Q. What type of distension media should be used with the MyoSure system?

A. The MyoSure system removes pathology via mechanical energy vs. electrical energy and therefore can use saline which is a physiologic distension media. Saline or Ringer’s Lactate, according to AAGL fluid management guidelines, have a higher intravasation safety limit (2500 cc) than is available for non-electrolyte media such as glycine (1000 cc). It should be noted, however, that the MyoSure procedure is compatible with all distension media.1

Q. Can the MyoSure system truly be used with any hysteroscopy pump?

A. Yes, however some pumps have more optimal performance. Any pump which does not have the ability to control flow rate should be considered sub-optimal. Sub-optimal pumps may be adequate for smaller pathology less than 3 cm, but may present distension or visualization challenges with larger and more complex pathology.

Can we perform the MyoSure procedure in the office?

A. Yes, the MyoSure procedure can be performed in the office. Learn More

 

REFERENCES:

  1. Miller C, Glazerman L, Roy K, Lukes A. Clinical evaluation of a new hysteroscopic morcellator – Retrospective Case Review. Journal of Clinical Medicine 2(3):163-166, July/August 2009.