Omni Lok Cervical Seal

Set, Seal, and See.

The Omni Lok cervical seal is designed to reduce fluid leakage, to help maintain distention, decrease clean up time after hysteroscopy, and improve procedural efficiencies in the OR.1,2,3,4

How it works:

 

Omni Lok Steps

Watch the product animation:

 

The MyoSure REACH device

Small Move, Big Difference

With the MyoSure REACH device, you can reach for the far corners of the uterus with confidence and accuracy to get to the hard-to-reach pathology.

MyoSure REACH

When compared with the current design, the MyoSure REACH device offers:

A shorter distance from the cutting blade to the distal tip—less than 1 mm—designed for easier access to polyps and fibroids up to 3 cm.

When resecting tissue simulated in the upper region of the uterine cavity, the MyoSure REACH device gets three times closer to the uterine model wall than the predecessor device—and removes 25% more tissue.*

 

*Based on internal bench testing that measured average relative height change of simulated 2 cm diameter tissue resected from a uterine model by 11 surgeon users.

Image of MyoSure Manuel device requirements - 1l saline bag, myosure hysteroscope, inflow/outflow tubing

This device allows you to REACH with confidence and may offer the added benefits of:

  • Complete resection of benign lesions may decrease likelihood of symptom recurrence.1
  • Easier access to hard-to-reach pathology can help to improve operative efficiency.

The MyoSure Tissue Removal Suite

About the MyoSure procedure

For a full spectrum of intrauterine procedures

The tissue removal device you choose is just one part of the complete MyoSure suite. The full set of MyoSure devices give you a solution for tissue removal in a wide range of sizes and locations.

View of myosure equipment and tools

NovaSure RFC10 Controller

THE NovaSure RFC10 Controller
Enhanced RFC10 controller for improved workflow

Working closely with customers, Hologic engineers have incorporated several physician-inspired and patient-focused enhancements to the NovaSure RFC10 controller. Here’s how these intuitive graphics help to improve workflow.

workflow
1
Touchscreen Interface
The responsiveness of our advanced touchscreen interface is set to react to user input.
screen
2
Ablation Timer and Summary Screen
The ablation time and summary screen displays cumulative running ablation time and total ablation time at the end of the procedure. Length, width and power level are also displayed. The prior procedure data is also recoverable if the controller is powered off and on.
instructions
3
Procedural Instructions On Interface
When you encounter an error message, use the IFU procedural instructions displayed on the interface to walk through corrective actions.
alarms
4
Volume-Controlled and Mutable Alarms
Turn the alarms down—or mute them altogether—so that patients aren’t startled during the procedure. This is a great feature when performing the procedure in outpatients.

NovaSure Endometrial Ablation

Nearly two decades* of real-world experience – NovaSure Endometrial Ablation

3 Million patients treated and counting!1

Abnormal uterine bleeding (AUB) can dramatically affect a woman’s comfort, confidence, and quality of life. The NovaSure endometrial ablation procedure is a simple way to reduce or stop menstrual bleeding for women with AUB.

 

  • It’s quick — one time, five-minute procedure.
  • It’s safe and effective — proven with over 15 years of demonstrated clinical performance.
  • It’s simple — this minimally invasive procedure can be done in a doctor’s office.

In the pivotal study of the NovaSure system, 92.8% of patients were satisfied with the NovaSure procedure.2

NovaSure Procedure Efficacy

What you need to know about the NovaSure procedure

A UK study showed that 96% of women had reduction in bleeding at 5 years follow up and 90% avoided hysterectomy3 To date more than 3 million procedures have been performed worldwide.1

THE NOVASURE DEVICE

Comfort, control, confidence

The NovaSure ADVANCED device, which include a 3-dimensional bipolar electrode, delivers continuous suction to ensure proper contact with the endometrium and to remove vaporised tissue. An integrated proactive safety test is performed prior to the delivery of radiofrequency (RF) energy; insufflating the cavity using CO2, the system can detect pressure leaks to confirm uterine cavity integrity. The assessment is sensitive enough to detect a perforation as small as an 18-gauge needle.

The NovaSure ADVANCED device is designed to focus on patient comfort and ease of use, providing the tools to allow you control at every step:

NS logo clear background with SD

SMART-DEPTHTM TECHNOLOGY
Smart

 

The technology continuously monitors and measures tissue impedance and calculates the optimal power level required for the treatment of the cavity – based on uterine size.

Profile of head with star in middle

Unique

 

Our unique Moisture Transport® fluid removal system provides constant tissue contact with the array through integrated suction while simultaneously removing steam, blood, and other by-products.

Fingerprint

Safe

 

The Cavity Integrity Assessment (CIA) is a built-in safety test that confirms uterine cavity integrity, giving you the confidence to perform a safe and effective ablation for every patient.

Shield with tick in centre

The MyoSure LITE device

Visually Directed. Visually Confirmed.

The MyoSure LITE device can remove small polyps up to 3 cm, and you can also trust that the quantity and quality of the tissue collection will allow for histologic assessment. With the 6.25 mm diameter of the MyoSure hysteroscope, minimal dilation is required during a MyoSure LITE procedure.

MyoSure LITE

With the MyoSure LITE device you can:

  • Visualise the uterine cavity with the MyoSure hysteroscope.
  • Identify and remove suspect pathology for histological assessment.
  • Resect smaller and softer tissue.
  • Complete the procedure efficiently—without removing the hysteroscope.
Get EnLITEned
NICE HMB Guidelines NG88 recommend1:

For women with suspected submucosal fibroids, polyps or endometrial pathology:

  • Ensure that hysteroscopy services are organised to enable progression to ‘see-and-treat’ hysteroscopy in a single setting if feasible.
  • Obtain an endometrial sample only in the context of diagnostic hysteroscopy. Do NOT offer ‘blind’ endometrial biopsy to women with HMB.
95.2% Complete resection of polyps using MyoSure LITE2

The MyoSure LITE device lets you visualise the entire uterine cavity to get a quality tissue specimen.

The MyoSure XL device

The Difference In Blade Technology Is Clear

Efficiently remove a range of tissue types and sizes, from polyps to fibroids, with the MyoSure XL device. Designed to optimise cutting efficiency, the device offers:

  • Large cutting window
  • Suction on-demand*

MyoSure XL

The MyoSure XL device blade is composed of high-grade coated stainless steel with ultra hardness and wear-resistance. Its external bevel in hardened stainless steel offers the sharpness and durability you need to resect large, hard fibroids.

The handle of the MyoSure XL device includes a suction on-demand* button, giving you the control you need to help keep the field of view clear—a feature designed to help with challenging visualisation.

The MyoSure MANUAL device

What is the MyoSure MANUAL Device?

The MyoSure MANUAL device offers the ability to perform outpatient polypectomy and targeted biopsy under continuous visualisation with the MyoSure hysteroscope – without the complexity, logistics, and costs of the operating room. It is designed for outpatient procedures and to be easy to use.

MyoSure MANUAL

The Myosure MANUAL device helps you enhance the efficiency of routine intrauterine procedures:

  • Polypectomy of up to three 1-cm polyps
  • Targeted endometrial biopsy

The MyoSure MANUAL device also gives you confidence that you can access all 4 quadrants of the uterine cavity.*

MyoSure MANUAL

*Based on internal bench testing of a stimulated procedure in a uterine model after which surgeons were asked to state their level of agreement on a Likert scale. N=16 surgeon users.

 

Perform outpatient hysteroscopic procedures

Increase productivity and efficiencies, rely less on the OR:

  • Reduce time between facilities
  • Take control of scheduling your procedures
  • Improve the cost-effectiveness of procedures

 

 

What you will need

The MyoSure MANUAL device offers flexibility with simple, outpatient setup:

Image of MyoSure Manuel device requirements - 1l saline bag, myosure hysteroscope, inflow/outflow tubing

The MyoSure Hysteroscope

Two Scope Sizes, Many Procedures

Using just one scope—the MyoSure hysteroscope—you can perform all stages of the procedure, from diagnostic assessment through treatment. Two scope sizes are available to support your specific requirements.

MyoSure Hysteroscopes

The MyoSure system offers the choice of scopes in two sizes. These allow you to visualise—and as necessary, simultaneously treat—the intrauterine pathology. Each scope includes a working channel designed to accommodate the MyoSure tissue removal device.

Both the MyoSure and the MyoSure XL hysteroscope feature:

  • Seal design that helps prevent fluid splash.
  • Continuous flow with removable outflow channel.
  • Working length of 18.4 cm.
  • 0⁰ direction of view and 80⁰, as well as a wide view of the uterine cavity.
  • Operative O.D. of 6 mm and 7 mm (XL), which minimises dilation.
  • The flexibility to support multiple light source attachments.

The MyoSure sterilisation instrument tray allows you to properly store and reprocess the MyoSure hysteroscope, ensuring that the scope and removable outflow channel are kept immobile to prevent damage. For complete sterilisation parameters, please consult the MyoSure Instrument Tray IFU – refer to the Resources section for full details.

The instrument tray is compatible with the following sterilisation systems:

  • UK standard cycle – steam autoclave at 134-137oC for 3-4 minutes and a 30 minute dry time, do not exceed 140oC
  • Automated washing process – washer-disinfector meeting requirements of the ISO 15883 series* (STEELCO “DS 50 DRSD” or equivalent)
  • Steam pre-vacuum sterilization (pre-vacuum autoclave)
  • Steam gravity displacement sterilization (gravity autoclave)
  • STERRAD® 100S system

*BS EN ISO 15883 Washer Disinfectors

The MyoSure Controller

The compact, easy-to-use MyoSure controller includes a power switch, tissue removal system timer display, a flexible drive cable connector for the tissue removal device and foot pedal connector.

The foot pedal allows you to maintain precise control of the tissue removal device.

At just 5.4 pounds and less than 12 inches long, the controller fits easily on top of a cart or other stable work surface.

Easy Operation

  • The system is turned on or off from the ON/OFF switch located on the front panel of the controller.
  • The controller’s power supply automatically detects the local power standard and adapts the tissue removal device to that standard.
  • The foot pedal controls tissue removal device operation. The foot pedal plugs into the connector on the front of the controller panel and is pneumatically operated.
  • The time display window indicates elapsed operating time for the tissue removal device in MIN:SEC format so you can track exactly how much time you have spent resecting tissue.
  • For cleaning the controller, simply wipe with a clean damp cloth and mild germicide or isopropyl alcohol.