GyneVue © 2018 by EndoVentions Medical, LLC

FAQs

Why is the GyneVue system being developed?

Hysteroscope technology has not seen significant advances over the past 30 years, notwithstanding the adaptation to video. Major changes in cost and how healthcare is delivered, however, has inspired development of multi-functional systems like GyneVue that address the concerns of an evolving health landscape.

The trend of moving procedures from the OR to an outpatient/office setting now requires managing an awake patient as well as managing costs. GyneVue’s ergonomic and economical design ensures the clinician can comfortably navigate the anatomy for better patient satisfaction while ensuring a viable practice.

GyneVue’s all-in-one modular system makes performing both diagnostic and operative procedures efficient, and cost-effective, and patient friendly, and feasible, regardless of procedural setting (especially advantageous in an outpatient/office environment).

GyneVue addresses the most common issues in performing hysteroscopy, and in particular, an outpatient setting/office practice:

  • Supports managing awake patients

  • Ensures proper and comfortable navigation of the anatomy

  • Promotes ‘the right tool is used for the right job’ through the innovative modular design

Furthermore, the GyneVue system reduces the operating space footprint, minimizes high equipment costs, and delivers advanced, high quality, robust digital chip visualization technology at an economical price. In this new era, doctors must be more cognizant of the business of delivering economical healthcare while ensuring positive patient outcomes and satisfaction.

How does GyneVue compare to disposable hysteroscopes?

The GyneVue system offers tremendous versatility and utility with high-quality components, which are unmatched by disposable hysteroscopy options. The modular shafts were specifically designed to maximize efficiency in performing multiple procedures, including diagnostic, operative, and tissue removal/morcellation.

GyneVue was engineered to take into account anatomical variations (e.g., cervical diameter, length, and rigidity, uterine position) to ensure smooth hysteroscope introduction and to improve intra-uterine visualization while mitigating potential patient discomfort during the procedure.

What is the value of GyneVue’s procedure-specific design?

Each shaft was developed to simplify setup and optimize functionality. Additionally, the components are all sized and configured to ensure successful hysteroscopic surgical application in virtually all anatomical variations and all surgical site settings.

 

This is especially valuable as more and more hysteroscopy procedures are being performed in outpatient/office environments where the patient is awake during the procedure, providing a more patient-friendly experience.

Why are ergonomics important to the handle and shaft design?

GyneVue’s integrated, modular hysteroscope system and enhanced ergonomics helps the clinician preview and manage anatomical differences effortlessly during diagnostic, operative, and tissue removal procedures. It is through this innovative design that surgical outcomes are optimized and potential adverse events are avoided.

 

Female anatomy varies drastically, requiring specific instrumentation to perform each procedure efficiently and effectively. Well-designed ergonomics helps the clinician address certain patient management and procedural considerations, including:

• Thin patient vs large/adipose patient

• Pre-menopausal vs post-menopausal

• Nulliparous vs primiparous/multiparous

• Short vs long procedures

• Fluid management requirements

• Radiofrequency application

What are the benefits of minimal components?

While traditional hysteroscopic setups involve up to 8 components (scope, sheaths, light cable, light source, camera coupler, camera head, etc.), GyneVue’s minimalist design dramatically simplifies assembly and disassembly processes, offering a faster procedural turnaround time. 

 

Another advantage of limited componentry is less potential for damage, malfunctioning equipment, or contamination, meaning fewer maintenance requirements, repairs, and costs and quicker reprocessing times.

 

Finally, the small footprint of the GyneVue platform is portable and can be setup in virtually any procedural setting, minimizing disruption of valuable operating space.

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The GyneVue System vs. Other Hysteroscope Options:

A cost analysis based on 100 procedures a year.

Equipment/

acquisition cost

Disposable Digital Hysteroscope

Traditional Rod Lens Hysteroscope

The GyneVue System

$150/procedure

 

$15,000

$9,000

Reprocessing/

Maintenance

$0

 

$68/procedure

$57/procedure

Total Cost Over

1 Year

$15,000

 

$21,800

$14,700

Total Cost Over

3 Years

$45,000

 

$35,400

$26,100

1

2

4

3

1

Includes labor, reprocessing materials, maintenance, repairs.

2

Equipment acquisition cost + reprocessing/ maintenance yearly costs.

3

Hysteroscope, sheath, compact video system

4

Includes all three shafts!

GyneVue is pending 510K clearance