FDA clears easy to use, low-cost Luminelle DTx Hysteroscopy/Cystoscopy system in the US

UVision360's, a Raleigh, N.C.-based company announced that its Luminelle DTx hysteroscopy system used for performing both hysteroscopy and cystoscopy won FDA clearance for sale in the US.

The Luminelle DTx Hysteroscopy System is simplified, easy to navigate, fully integrated hysteroscopy system designed for benefits for patients and physician alike.

It enables the physician to perform diagnostic and operative procedures in the office with 75% less investment as compared to traditional endoscopy tower systems. Patients can rip the benefits of faster procedural and recovery time along with cost savings.

The system features a two-part single-use protective sheath consisting of the introducer and 360° Rotating sheath. The introducer thoroughly covers the scope thereby protecting it against bodily fluid and reducing contamination to the minimum. It also separates the inflow and outflow channels to manage the irrigation fluids. The operative channel enables biopsies and polypectomies under direct visualization.

The 360° Rotating sheath facilitates ease of movements and 360° view of the uterine cavity. The flexible 2.0 mm scope is equipped with the latest CMOS micro-technology for a high resolution, high definition view of the inside of uterus and bladder to a depth of 45-55 mm. Specially designed visualization software comes with auto-adjusting lighting for more comfortable viewing of cavities.  The whole procedure can be monitored via HDMI or USB 3 for PC or Mac systems, making use of systems already existing in the office.

Dr. Amy Garcia, MD FACOG; Director – Center for Women's Surgery; Institute for Hysteroscopy Training, Albuquerque, NM explains, "Since the best technology is typically only available in the operating room, many physicians and patients opt to skip the hysteroscopy and either perform a blind biopsy or go straight to surgery, without taking a good look inside of the uterus. An in-office system that is easy to use prevents a blind biopsy and allows the physician to offer either a therapeutic diagnosis or a biopsy under visualization elevates the standard for uterine care."

Allison London Brown, CEO of UVision360 said in a news release, "Most operating room equipment is cost and space prohibitive for standard office use. We created an elegant and ergonomic system with visualization quality comparable to that of the OR, and that is comfortable for both physician and patient."

"Our system is a fully-integrated hysteroscopy/cystoscopy system with a value-based cost to provide better accessibility for the changing needs of today's GYN. The combined features lead to the potential for better care for women, earlier detection, and improved health outcomes," she further added.

Product overview

News Release

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News from NAMS 2017: Postmenopausal bleeding is always a red flag, unless proven benign

Every postmenopausal bleeding mandates a complete and systematic investigation to rule out endometrial malignancy and blind biopsies are no longer the norm, according to a presentation by Steven R. Goldstein, MD, a professor of obstetrics and gynecology at New York University School of Medicine, New York City here at the North American Menopause Society (NAMS) 2017 Annual Meeting.

“If you’re postmenopausal and not on hormone therapy or tamoxifen, you shouldn’t be bleeding,” he further added.

American Cancer Society estimates that in year 2017, about 61,380 new cases of endometrial cancer and uterine sarcoma will be diagnosed and about 10,920 women will die from these cancers. The average age at diagnosis is 60 and postmenopausal bleeding is the most common presentation in nearly all the cases.

In majority of women who present with postmenopausal bleeding, the cause is atrophic changes of endometrium or vagina, but depending upon other risk factors, 1-14% of these women will harbor a malignancy and it is important not to miss these women.

ACOG advocates endometrial evaluation in any women presenting with abnormal uterine bleeding (AUB), but blind biopsy is no longer sufficient in ruling out uterine malignancy.

Blind biopsy alone could miss the diagnosis of focal lesions in up to 18% of patients
Endosee

Dr Goldstein said, “The standard of care has changed. Now the standard of care corroborates that a negative blind biopsy is not a stopping point. Clinicians can still begin with a blind biopsy, but unless it is malignant or complex atypical hyperplasia, the endometrial evaluation is not complete."

If cancers occupy less than 50% of the surface area of the uterine cavity, it can very much be missed with a blind biopsy.

if cancer occupies less than 50%, of the surface area of the endometrial cavity, the cancer can be missed by a blind biopsy
Endosee

The Evaluation Algorithm

The investigation should ideally begin with transvaginal ultrasonography(TVS), or sonomicroscopy, to determine the thickness of the endometrium. If distinct endometrial echo or lining, less than or equal to 4 mm is visualized, no further endometrial sampling is required. (99.8%- 100% negative predictive value)

But, in many patients it is not possible to see the endometrial lining because of obesity, adenomyosis structural nonalignment or fibroids.  So, if the endometrial thickness is more than 4 mm or the endometrial echo is difficult to visualize, the next logical step is to perform a sonohysterography or hysteroscopy.

By infusing fluid, clinicians can delineate clearly whether the thickening is focal or global throughout the cavity. If the thickness is global, go for a biopsy. If it is focal occupying more than 20-30% of uterine cavity, plan for a biopsy under hysteroscopic guidance.

It’s easy and timesaving to perform office hysteroscopy, with US FDA approved disposable hysteroscope called Endosee (Cooper Surgical). It provides a quick point of care option and does not require sterilization or special storage. Physicians can take a biopsy under direct vision and resolve the dilemma.

If the patient’s first point of contact is not an obgyn but a primary care physician, an internist or physician from some other specialty, they should at least order a TVS, so that by the time the patient is seen by a gynecologist, the initial sonography report is ready.

NAMS press release

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