HARMONIC ACE+7 Shears with Advanced Hemostasis

Less tissue damage and a significantly smaller thermal footprint compared to leading competitors^1-7*

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HARMONIC ACE+7 Shears with Advanced Hemostasis

Dissection and Vessel Sealing

HARMONIC ACE+7 Shears were the first ultrasonic energy device with a 7mm vessel sealing indication^8≠

HARMONIC ACE+7 may reduce the number of surgical devices needed to achieve hemostasis⁹

HARMONIC ACE+7 was shown to reliably seal the IMA (n=40)^10±

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Adaptive tissue Technology

Adaptive Tissue Technology power modulation reduces delivery of unnecessary energy, enabling more precise energy application.^11≥

HARMONIC ACE+7 delivers significantly lower temperatures with Adaptive Tissue Technology thermal management than without Adaptive Tissue Technology thermal management in the Advanced Hemostasis mode.^12π

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References

*In a preclinical study on 5-7mm goat carotids vs. LigaSure™ Blunt Tip and 5mm porcine carotids vs. Thunderbeat (TB-0535FC) using Advanced Hemostasis mode, mean thermal damage was significantly different compared to HARMONIC™ ACE™+7 (p=0.003 and p=0.002, respectively). In a preclinical study on ≤5mm porcine carotids vs. LF1637 (Power Level 2) and vs. TB=0535FC (Seal and Cut Mode). Mean damage compared and determined via histology (p<0.001). Footprint = Lateral thermal damage (right + left) + jaw width.

≠Internal market analysis as of 31 Jan 2014

±As shown in an observational study. First pass hemostasis on IMA (100%)

≥Based on preclinical studies, HARMONIC™ ACE™ with Adaptive Tissue Technology (Power Drop and Tones) demonstrated decreased activation times and thermal damage vs. HARMONIC™ ACE™ without Adaptive Tissue Technology

πIn a benchtop engineering study on porcine carotids where Adaptive Tissue Technology was intentionally turned off

1. Ethicon, SCN033130C, HARMONIC™ ACE™+ 7 with Advanced Hemostasis (HARH23, HARH36, and HARH45) is not significantly different than HARMONIC™ ACE™+ 7 with
Adaptive Tissue Technology (HAR23 and HAR36) in power levels 1-5, Feb 2014, Data on File (157590-201030)

2. Ethicon, PCS0000215, Harmonic ® HARH36 and HARH23 Shears: Acute 5-7mm Vessel Study in the Goat – Performance and Lateral Thermal Damage, April 2014, Data on File (157590-201030)

3. Ethicon, PSP003620A, Project Q/MAC – HARH36: Verification Acute Study in the Goat, April 2014, Data on File (157590-201030)

4. Ethicon, PSP0003910A, Q/MAC vs LigaSure Thermal Damage Statistical Analysis, April 2014, Data on File (157590-201030)

5. Ethicon, PSP004469A, Lateral Thermal Damage of HARMONIC ACE® Shears HARH36 vs LigaSure™ 5mm Blunt Tip LF1637, and THUNDERBEAT 5mm TB-0535FC, May 2015, Data on File (157590-201030)

6. Ethicon, PSP004502B, Thermal Footprint Statistical Analysis, June 2015, Data on File (157590-201030)

7. Ethicon, PRC070771A, Device Measurements – Competitive Product Analysis, March 2015, Data on File (157590-201030)

8. Ethicon, SCN034259, Competitive Intelligence Ultrasonic Vessel Sealing Claims, January 2014, Data on File (145923-200708)

9. As Per Instructions For Use (157579-201030)

10. Plasencia G, Van der Speeten K, Hinoul P, et al, Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device. JSLS;2016;2;1 (116883-210802)

11. Ethicon, PSP005693A, Memorandum:HAR & ACE Size and Adaptive Tissue Technology Comparison Intra-operative and Histopathology, June 2017, Data on File (126027-191022)

12. Ethicon, PRC063849D, Q DV- Blade tip heat (HEMO), Sept 2014, Data on File (116890-210802)

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*As of March 2017, per internal research conducted by Ethicon.
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