Dive Brief:
- Hologic announced the U.S. launch of its latest scope for diagnostic and therapeutic uterine procedures that is designed to streamline treatment by combining three interchangeable sheath options in one device.
- The Omni hysteroscope received 510(k) clearance from FDA this month. The device can be used in physician offices, surgical centers or operating rooms, said Marlborough, Mass.-based Hologic, which specializes in treatments for women's conditions.
- The sheaths used with the device have been designed to be smaller in diameter for patient comfort and longer in length for easier treatment of obese patients.
Dive Insight:
The Omni scope allows the physician to view the cervical canal and uterine cavity for performing diagnostic and operative procedures. The device is intended to improve the procedure for treating uterine conditions by avoiding the need to change from a diagnostic to an operative scope.
The scope also is intended to improve on the traditional method of diagnosing and treating conditions of the uterus called dilation and curettage (D&C). In a D&C procedure, tissue is scraped and removed from inside the uterus.
Using the Omni scope, the physician can look in the uterine cavity for fibroids or polyps as well as biopsy or treat the pathology using the same scope with different sheath options.
"Experts agree that direct visualization of the uterine cavity in women with abnormal uterine bleeding is the gold standard that allows physicians to accurately identify and collect quality samples and remove pathology – in a safer and more effective manner than blind biopsy and curettage," Edward Evantash, Hologic's medical director and vice president of global medical affairs, said in a press release.
The scope's features include optics and sheaths in 3.7 mm size for diagnostics and 5 mm and 6 mm sizes for operative treatment. The 200 mm length facilitates treatment of obese patients. The scope can be used with Hologic's Fluent hysteroscopic fluid management system and is compatible with all of the company's MyoSure tissue removal products.
