A multifunctional vessel sealing instrument that delivers reliable sealing with precise control of thermal effect

Transcription

1 A multifunctional vessel sealing instrument that delivers reliable sealing with precise control of thermal effect

2 Laparoscopic Shears are an intelligent, multifunctional thermal vessel sealing instrument that uses ferromagnetic technology to efficiently seal and divide tissue with minimal lateral thermal spread in laparoscopic and open surgical procedures. Reliable sealing of vessels up to 7 mm in diameter, including lymphatics Faster dissection times than competitive instruments through vascular tissue bundles Precise control of heat, with less lateral thermal spread than competitive instruments No stray electrical current, no risk of capacitive coupling, safe to use around metal staples and clips Laparoscopic Shears are a component of the Ferromagnetic Surgical System

3 The sealed vessels with clinically reliable burst pressures consistent with other technologies currently available. The compared favorably with the other technologies in speed and efficiency as well as tissue effects, including thermal spread and injury. Chen J, Manwaring PK, Scott RR, Manwaring KH, Glasgow RE. Ferromagnetic Heating for Vessel Sealing and Division: Utility and Comparative Study to Ultrasonic and Bipolar Technologies. Surgical Innovation Indicated for sealing vessels up to 7 mm in diameter, including lymphatics, in laparoscopic and open procedures Electrically silent operation, no stray current, safe to use around metal staples and clips FMmin and FMmax activation modes Patented active cooling system ensures localization of heat in the jaws and rapid cool down 5 mm diameter shaft for use with standard 5 mm trocars Curved, non-stick jaws can be rotated 340 Ferromagnetic heating can be activated while compressing the jaws to seal and divide vascular tissue bundles Compatible with reusable or disposable FMX Power Modules activation modes and power settings Seal Only Mode: Used to seal large vessels; > 2 mm in diameter* Seal & Divide Mode: Used to seal & divide large vessels; > 2 mm in diameter* with single button activation High Power Seal & Divide Mode: Used to quickly seal & divide vascular tissue bundles, membranes, and small vessels Pulsed audio tone indicating activation of vessel sealing cycle - followed by three short beeps indicating completion of the cycle. If desired, FMmax button can be activated to divide the sealed vessel Pulsed audio tone indicating activation of vessel sealing cycle - followed by continuous audio tone indicating automatic transition to delivery of high power energy to divide the sealed vessel Continuous audio tone indicating activation of high power energy to simultaneously seal & divide tissue bundles, membranes, and small vessels * Based on surgeon experiences and feedback

4 Reliable Vessel Sealing Vessel sealing reliability and burst pressure measurements are comparable to bipolar laparoscopic vessel sealing instruments No stray electrical current passes through the patient, no risk of capacitive coupling, safe to use around metal staples and clips Speed and Efficiency Faster sealing and dividing cycles than competitive instruments Dual activation modes put full control of thermal effect in the hands of the surgeon Sealing Reliability Analysis Vessel sealing tests were performed using Laparoscopic Shears and laparoscopic vessel sealing instruments on porcine arteries ranging between 3 and 7 mm in diameter in a controlled laboratory setting. The percentage of overall seals that resulted in burst pressures above 240 mmhg, are shown below. Burst Pressure Analysis Burst pressure comparisons were performed using Laparoscopic Shears and laparoscopic vessel sealing instruments on porcine arteries ranging between 3 and 7 mm in diameter. Each vessel was sealed, divided, and pressurized using an automated inflation system until the seal failed. Average burst pressure results in mmhg are shown below. Dissection Speed Test Speed tests were performed using Laparoscopic Shears,, and Harmonic laparoscopic vessel sealing instruments. A 10 cm section of porcine mesentery was measured and marked prior to dissection. Each instrument was used to seal and divide the pre-measured segments. Multiple rounds were completed with each instrument, and the average time to complete each 10 cm dissection is shown below. 100% % 96% 94% n = seconds 92% % 88% 86% 90% success 91% success mmhg 896 mmhg Harmonic n = seconds 84% 500 SD = % SD = % 0% n = 376 n = n = 376 n = 476 n = seconds

5 Minimal Thermal Injury Pure thermal effect with less lateral thermal spread than bipolar and Harmonic ultrasonic laparoscopic vessel sealing instruments Laparoscopic Shears are actively cooled, providing lower operating temperatures than Harmonic ultrasonic laparoscopic vessel sealing instruments Lateral Thermal Spread Analysis To determine lateral thermal spread, porcine arteries ranging between 4 and 5 mm in diameter were sealed and divided using Laparoscopic Shears,, and Harmonic laparoscopic vessel sealing instruments. 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 instrument FMX Generator features a patented software control algorithm that continuously monitors and adjusts the delivery of energy to the tissue, ensuring that the optimal amount of heat is delivered at all times. FMX Generator offers multi language support through its graphical user interface MDEA Gold Award Winner FMX Power Modules connect FMX surgical instruments to the generator, and intelligently manage the communication throughout the system. n = mm SD =.34 FMX Surgical Instruments have been designed to bring the unique clinical benefits of ferromagnetic technology to a wide range of surgical sub-specialties. Harmonic n = mm SD =.39 The FMX Ferromagnetic Surgical System harnesses state-of-the-art technology to achieve unparalleled simplicity. To prepare the FMX system for use, follow these simple steps: n = mm SD =.43 1 Plug the FMX Power Module into the front panel of the FMX Generator 2 Snap the power module into the back of the 3 Set the MIN power setting on the generator and the is ready Harmonic Histologic analysis of comparative seals using a laparoscopic vessel sealing instrument (left), Harmonic laparoscopic vessel sealing instrument (middle), and Laparoscopic Shears (right) in porcine arteries. Black lines indicate measurements of thermal damage. Utilizing a single power module, multiple FMX instruments can be swapped out at any time during surgery. Simply remove the power module and snap it into any other FMX instrument. The generator remembers each instrument s previous power setting, making the instrument swap fast and seamless. Internal data on file

6 Domain Surgical 1370 South 2100 East Salt Lake City, UT (801) web: domainsurgical.com To watch surgical videos of FMX instruments in action, visit domainsurgical.com/video To learn how ferromagnetic technology works, visit domainsurgical.com/fmx For additional information on the advantages and safety considerations of the FMX System, please visit domainsurgical.com. For patent information, please visit domainsurgical.com/patent Domain Surgical, Inc. All rights reserved. LB-054 Rev. B