Clinical Evidence

Preclinical Testing: Seal Performance

The ability to reliably seal vessels up to and including 7 mm is a key consideration when selecting an advanced energy device for surgery. Rated Burst Pressure is widely recognized as the standard measure for testing seal strength. Seal reliability is also an important consideration. In preclinical testing, the THUNDERBEAT Open Fine Jaw provided the highest average burst pressure and seals that withstood greater than 3x systolic pressure.

Burst Pressure

In rated burst pressure testing, the THUNDERBEAT Open Fine Jaw provided a 22% higher rated burst pressure than LigaSure™ Small Jaw. The Harmonic FOCUS®+ Shears was not tested as the device does not have a 7 mm vessel sealing indication.

Seal Success

The rate of seal success and seal failure was calculated for vessel sizes up to and including 5 mm. Seal success was defined as a burst pressure greater than 360 mmHg (3x systolic pressure). Seal failure was defined as a burst pressure less than 360 mmHg. A sample size of 90 was used for each device.

Results: 100% of THUNDERBEAT Open Fine Jaw seals withstood burst pressures great than 360 mmHg. While 8.9% of Harmonic Focus seals burst at pressures below 360 mmHg.

Preclinical Testing: Dissection and Grasping

Through the unique design combining integrated energy with the center-pivot wiper jaw, the THUNDERBEAT Open Fine Jaw is one of the most versatile and precise instruments on the market. The revolutionary jaw is designed to act as a dissecting and grasping instrument. This is achieved through the consistent pressure across the jaw; enabling the highest tip grasping force, the finest curved tip design and the strong jaw opening forces. This can contribute to less instrument usage, fewer instrument exchanges, uninterrupted surgical flow, and total OR time savings.

The THUNDERBEAT portfolio incorporates the center-pivot wiper jaw design which enables consistent pressure across the tissue/vessel to provide the highest tip grasping force. Conventional hinged jaw instruments, LigaSure Small Jaw and Harmonic FOCUS+ Shears, provided variable pressure with less pressure at the tip.

Preclinical Testing: Tissue Cutting Speed

Ultrasonic energy devices use low frequency vibration which result in mechanical energy for cutting and coagulation. Bipolar devices require a mechanical blade and multiple steps to cut, sacrificing rapid cutting. As part of the THUNDERBEAT portfolio, the Open Fine Jaw seal & cut mode delivers bipolar and ultrasonic energy simultaneously; enabling best-in-class cutting speed. Faster cutting speed can contribute to a total OR time savings.

In cutting speed testing across 20 cm of porcine mesentery, the THUNDERBEAT Open Fine Jaw provided a 112% and 81% faster cutting speed than the LigaSure Small Jaw and the Harmonic FOCUS+ Shears respectively.

Preclinical Testing: Thermal Spread

In open ENT surgery, there are instances where energy is activated in close proximity to thermally sensitive structures such as nerves and parathyroid glands. Therefore, when selecting an advanced energy device, thermal spread is of utmost importance. The THUNDERBEAT Open Fine jaw provided an average lateral thermal spread of < 2 mm.

Objective: The objective of this in vivo study was to evaluate the tissue effect of the THUNDERBEAT Open Fine Jaw compared to predicate advanced energy devices for open surgery (LigaSureTM Small Jaw and Harmonic FOCUS+ Shears) in an established porcine model.

Methods: Vessels were sealed and collected for histological analysis of thermal damage.

Results: In preclinical testing, all three advanced energy devices provided average lateral thermal spreads of < 2 mm. Therefore depending on the operative situation, staying 2–3 mm away from thermally sensitive structures is advised.

Articles

• Ultrasonic, bipolar, and integrated energy devices: comparing heat spread in collateral tissues – Megan K. Applewhite, MD, MA, Michael G. White, MD, Benjamin C. James, MD, Layth Abdulrasool, MD, Edwin L. Kaplan, MD, Peter Angelos, MD, PhD and Raymon H. Grogan, MD, Journal of Surgical Research (article in press).
• Olympus supplements its THUNDERBEAT portfolio

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