Product Review

Product update: Neuromodulation device, cystoscopy simplified, hysteroscopy seal, next immunization frontier



Axonics Modulation Technologies, Inc. announced the first implantation of its recently US Food and Drug Administration (FDA)-cleared, implantable, rechargeable sacral neuromodulation device. The implantation was the first to occur outside of a clinical study setting. The device is designed to reduce urinary and bowel dysfunction symptoms and reestablish pelvic floor function by restoring communication between the bladder and bowel to the brain. The Axonics r-SNM System is the first sacral neuromodulation device to be sold in the world. It is a miniaturized neurostimulator approximately the size of a USB stick and is qualified to operate for at least 15 years. The device can be safely left in place during full-body magnetic resonance imaging, says Axonics.



Hologic has expanded its hysteroscopy portfolio with the launch of its Omni™ Lok cervical seal. The seal is designed to help maintain uterine distention and improve procedural efficiency in the operating room (OR) by minimizing fluid leakage during hysteroscopic procedures. Hologic says that Omni Lok is compatible with the MyoSure® and Omni™ hysteroscopes and reduces fluid leakage by an average of 94%. The Omni Lok cervical seal is commercially available in the United States and Canada. The device should not be used in a patient with a contraindication to hysteroscopy, says Hologic.

For more information, visit:


Emmy Medical announces the CystoSure® XL, an all-in-one silicone urinary catheter with an additional port for the introduction of a conventional hysteroscope to conduct simple cystoscopy. An addition to the CystoSure Silicone Cystoscopy Catheters, the new CystoSure XL provides a solution for the surgeon to view the bladder in every patient every time without the need to open and introduce a complete cystoscopy tray and instrumentation, says Emmy. According to the manufacturer, the CystoSure System combines the familiarity of a urinary catheter with the functionality of a cystoscope into a singular product providing easy viewing access of the bladder at any time in an OR or office procedure.



Pfizer announces that it is embarking on the next frontier in vaccine immunization by conducting several studies of infant protection through maternal vaccination. While no vaccine currently is licensed for use in pregnant women to protect her infant, multiple studies have demonstrated that this can be done, says Pfizer. The company is currently investigating, in phase 1 and 2 studies, vaccines for Group B Streptococcus (GBS) and respiratory syncytial virus (RSV).

Globally, there are 410,000 cases of GBS every year. GBS is most common in newborns; women who are carriers of the GBS bacteria may pass it on to their newborns during labor and birth. An estimated 10% to 30% of pregnant women carry the GBS bacteria. The disease can manifest as sepsis, pneumonia, and meningitis, with potentially fatal outcomes for some. A maternal vaccine may prevent 231,000 infant and maternal GBS cases, says Pfizer.

According to Pfizer, RSV causes more hospitalizations each year than influenza among young children, with an estimated 33 million cases globally each year in children less than age 5 years.


Recommended Reading

Can the office visit interval for routine pessary care be extended safely?
MDedge ObGyn
Is elagolix effective at reducing HMB for women with varying fibroid sizes and types?
MDedge ObGyn
Eating for 2: Managing eating disorders in pregnancy
MDedge ObGyn
What is optimal hormonal treatment for women with polycystic ovary syndrome?
MDedge ObGyn
Should secondary cytoreduction be performed for platinum-sensitive recurrent ovarian cancer?
MDedge ObGyn