FMsealer™ Vessel Sealing Shears

FMsealer Vessel Sealing Shears

FMsealer Open Shears (left) and Laparoscopic Shears (right)

FMsealers are intelligent, multifunctional thermal vessel sealing instruments that use ferromagnetic technology to efficiently seal and divide tissue with minimal lateral thermal spread in open and laparoscopic surgical procedures.

Reliable Vessel Sealing

  • Indicated for sealing vascular tissue bundles and vessels up to and including 7 mm in diameter, including lymphatics, in both open and laparoscopic procedures
  • Vessel sealing reliability comparable to or better than industry-leading bipolar devices
  • Burst pressure measurements comparable to or better than bipolar devices

Minimal Thermal Injury

  • Pure thermal effect with less lateral thermal spread than competitive devices
  • No stray electrical current, no risk of capacative coupling, safe to use near metal staples and clips

Speed and Efficiency

  • Faster transection sealing and dividing cycles than competitive devices
  • Efficient hemostatic dissection of vascular tissue bundles
  • Dual activation modes let surgeon toggle between quick, hemostatic transection and slower, reliable large vessel sealing

Videos of the FMsealer in Action

Transhiatal Esophagogastrectomy Using FMX Instruments - Domain Surgical's FMwand and FMsealer surgical instruments are used to perform a transhiatal esophagogastrectomy. Surgery performed by Dr. Robert Glasgow.

Sarcoma Resection Using FMX Instruments - Domain Surgical's FMwand and FMsealer surgical instruments are used during a sarcoma resection procedure. Surgery performed by Dr. Robert Andtbacka.

FMsealer Open Shears Porcine Mesentery Speed Test - Preclinical test comparing the relative speed of the FMsealer Open Shears, LigaSureā„¢ small jaw, and Harmonic Focus® in transecting 10 cm of porcine mesentery.

FMsealer Design Features

Design Features

  • Patented active cooling system ensures localization of heat in the jaws and rapid cool down
  • Electrically silent operation, no stray current, safe to use around metal devices, staples, and clips
  • Ferromagnetic heating can be activated while compressing the jaws to seal and divide vascular tissue bundles
  • Features dual MAX and MIN activation modes
  • For use with FMX Power Modules
  • FMsealer Open Shears (left): Curved, non-stick jaws are over 30% longer than Harmonic Focus® and LigaSure™ small jaw
  • FMsealer Laparoscopic Shears (right): 5 mm diameter shaft for use with standard 5 mm trocars - curved, non-stick jaws can be rotated 340°

Dual Activation Modes

Unlike other vessel sealing devices, the FMsealer features dual activation modes that give the surgeon the ability to choose the appropriate energy delivery mode to achieve the desired clinical effect. FMmin mode is used to reliably seal large vessels. The power setting for FMmin can be set to either 1 or 2 on the LCD touchscreen of the generator. FMmin 1 is a seal-only mode, while FMmin 2 is a seal-and-divide mode. FMmax mode is used to quickly seal and divide vascular tissue bundles, membranes, and small vessels. FMmax mode can only be set to a power setting of 3, the highest power that the device will deliver.

FMmin 1 Mode

While pressing and holding the FMmin button of the FMsealer, the generator sounds a pulsing audible tone, indicating FMmin 1 mode is activated. When the vessel sealing cycle is finished, three short beeps are sounded, and delivery of energy stops. The surgeon can release the vessel to leave it sealed, or manually activate the FMmax button to divide the sealed vessel.

FMmin 2 Mode

While pressing and holding the FMmin button of the FMsealer, the generator sounds a pulsing audible tone, indicating FMmin 2 mode is activated. When the vessel sealing cycle is finished, the audible tone transitions to a continuous tone and the generator delivers full power to automatically divide the vessel. If desired, a vessel can be sealed without dividing by opening the jaws first, and then releasing the activation button before separation occurs.

FMmax 3 Mode

While pressing and holding the FMmax button of the FMsealer, the generator sounds a continuous audible tone, indicating FMmax 3 mode is activated. FMmax mode simultaneously seals and divides tissue bundles, membranes, and small vessels in a single action.

FMX Power Modules

FMX Power Modules

FMX Power Modules connect the FMsealer to the generator and intelligently manage communication between each component within the system. FMX Power Modules are available in both reusable and single-use disposable configurations. The FMX Reusable Power Module (left) can be autoclave resterilized for use in up to 100 procedures, providing a cost-effective option for the hospital. The FMX Disposable Power Module (right) is single-use only and is discarded following each surgical procedure.


  FMX Reusable Power Module (RPM) Directions for Use

  Read more about FMX ferromagnetic surgical technology and how it works.

Clinical outcomes that truly make a difference

Vessel Sealing Reliability

Vessel sealing data was collected using LigaSure™ vessel sealing devices and FMsealer devices on vessels ranging between 2-7 mm in diameter in a controlled laboratory setting. The percentage of overall seals that resulted in burst pressures above 240 mmHg, which is twice the average human systolic blood pressure, are shown below.

Open Vessel Sealing Devices

FMsealer Open Shears Vessel Sealing Reliability

Laparoscopic Vessel Sealing Devices

FMsealer Laparoscopic Shears Vessel Sealing Reliability

Burst Pressure Analysis

To measure average burst pressures, vessels ranging between 2-4 mm were sealed and cut. Each vessel was then pressurized with saline using an automated inflation system until the seal failed. Burst pressure measurements in mmHg were rerecorded and then analyzed. Average burst pressure results are shown below.

Open Vessel Sealing Devices

FMsealer Open Shears Vessel Sealing Burst Pressures

Laparoscopic Vessel Sealing Devices

FMsealer Laparoscopic Shears Vessel Sealing Burst Pressures

Lateral Thermal Spread

To determine average lateral thermal spread, porcine arteries ranging between 4 and 5 mm in diameter were sealed and divided using Harmonic® vessel sealing devices and FMsealer devices. After sealing and dissection, each artery was harvested. HE staining and histologic assessment of lateral thermal spread was performed by an independent reviewer. Lateral thermal spread was determined to be the maximum distance thermal injury extends laterally from the edge of the device. Average lateral thermal spread is shown in the charts below. Histologic images below show visual analysis of comparative seals. Black lines indicate measurements of thermal damage.

Open Vessel Sealing Devices


FMsealer Open Shears Lateral Thermal Spread
FMsealer Open Shears Lateral Thermal Spread

Harmonic Focus (left) and FMsealer Open Shears (right)

Laparoscopic Vessel Sealing Devices


FMsealer Laparoscopic Shears Lateral Thermal Spread
FMsealer Laparoscopic Shears Lateral Thermal Spread

Harmonic Ace (left) and FMsealer Laparoscopic Shears (right)

Speed and Efficiency

Comparative tests were conducted to determine the relative speed and efficiency of LigaSure, Harmonic, and FMsealer devices. A 10 cm section of porcine mesentery was measured and marked prior to dissection. Then, each device was used to seal and divide the pre-measured segments. Multiple rounds were completed with each device, and the average time to complete each 10 cm dissection is shown below.

Open Vessel Sealing Devices

FMsealer Open Shears Speed and Efficiency

Laparoscopic Vessel Sealing Devices

FMsealer Laparoscopic Shears Speed and Efficiency

FMsealer provides extremely reliable and consistent vessel sealing. FMsealer also performed faster than competitive devices in sealing and dividing vascular tissue, with the least amount of lateral thermal injury.

 

Bipolar

Ultrasonic

FMsealer

Simple setup, plug-and-play capability

Electrically silent operation, elimination of stray electrical current

Safe for use around metal staples and clips

7 mm vessel sealing indication

Minimized thermal spread

Best-in-class speed of dissection

Single step seal-and-divide functionality

Eliminates use of mechanical blade to divide tissue

Cuts to distal edge of seal



Published Clinical Evidence

Using the FMX Ferromagnetic Surgical System

The FMX Ferromagnetic Surgical System combines state-of-the-art surgical technology with unparalleled ease-of-use and simplicity. Prepare the FMsealer by following these simple steps:
FMX Generator

1

Plug the FMX Power Module into the front panel of the FMX Generator

2

Snap the power module into the back of the FMsealer device

3

Set the power settings on the generator and the FMsealer is ready

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