INNOVATION. Harmonic INSPIRED BY TRADITION. HARMONIC FOCUS + Long Shears with Adaptive Tissue Technology

Transcription

1 INNOVATION INSPIRED BY TRADITION HARMONIC FOCUS + Long Shears with Adaptive Tissue Technology Precise, controlled dissection Consistent, reliable seals* Access and visibility in deep spaces *In a pre-clinical study, 100% (32/32) of porcine blood vessels remained hemostatic over a 30 day survival period (p=1.000)

2 For open procedures Introducing the HARMONIC FOCUS + Long Shears with Adaptive Tissue Technology A single, versatile, open-surgery device that can dissect, seal, and transect This advanced energy ultrasonic instrument is designed to bring a new level of operative efficiency to your open procedures. A multifunctional device with a 17-cm shaft, slim profile, curved tip, and familiar scissor-like handling for outstanding access and visibility, controlled dissection, and the ability to simultaneously dissect, seal, and transect. Thin Profile & Bi-Directional Jaw Curved, fine 16 mm tip for precise dissection Maximizes visibility in tight spaces Extended Reach Long 17 cm length aids access and visibility in deep spaces Ergonomic Scissor Design Designed for open surgery to feel comfortable and familiar in your hand Controlled dissection with excellent tactile feedback Adaptive Tissue Technology Results in significantly lower and more consistent temperatures* Up to 13% cooler clamp arm temperature Provides enhanced audible feedback Comfort & Versatility 240 activation buttons allow for multiple hand positions *Based on temperature and temperature variance of device following multiple transections using porcine jejunal tissue Versus HARMONIC FOCUS Long Shears without Adaptive Tissue Technology, as exhibited in a benchtop transection study on porcine jejunum using an IR camera (P<0.05)

3 Experience the Advantages over Traditional Open Techniques Introducing the HARMONIC FOCUS + Long Shears for open procedures Access, visibility, and precise dissection The 17-cm shaft, slim profile, and long, curved tip enable access to deep anatomy, improved visualization of the operative field, and precise dissection. Improved hemostasis and reliable sealing* With HARMONIC Technology, the ability to simultaneously transect and coagulate results in less blood in the operative field, which may help improve visualization of key structures. Vessels up to 5 mm, as well as lymphatics, are consistently sealed and divided. Multi-functionality to enhance efficiency Less need for instrument exchanges, which may decrease operative time. Optimized ergonomics Designed for the demands of open surgery, with intuitive handling based on the familiar scissor-like design, bidirectional jaw movement, symmetrical finger rings for comfort and versatility, balanced to reduce fatigue, and 240-degree activation triggers that support multiple hand positions. * Versus conventional techniques In a prospective randomized study, patients with resectable adenocarcinoma of the stomach had a median blood loss of ml for ultrasonic and ml for conventional techniques (n=30 for each; P=0.016). Inoue K., et. al., Ultrasonic Scalpel for Gastric Cancer Surgery: a Prospective Randomized Study. J Gastrointest Surg (2012) 16:1840;1846. Based on preclinical testing of blood vessels and lymphatic vessels up to and including 5 mm and 1 mm in diameter, respectively

4 HARMONIC FOCUS + Long Shears in Open Procedures Designed for Improved Efficiency vs Traditional Techniques One multi-functional device puts the access, visibility, precision, and control you need in your hand with fewer instruments and instrument exchanges Improved access 17-cm shaft length to reach deep anatomy Slim profile for precision in tight spaces Better visibility Designed to optimize your sight line to the distal tip Coagulates as it transects to reduce bleeding into the operative field Enhanced control Ergonomic scissor-like design to optimize tactile feedback Wide jaw aperture for versatility in blunt dissection, spreading, otomy creation, and back-cutting Curved, fine tips for focused, precise dissection Improved heat management with minimal thermal spread ( 2 mm) to help protect vital structures From open to close with greater efficiency Versus HARMONIC FOCUS Long Shears without Adaptive Tissue Technology, as exhibited in a benchtop transection study on porcine jejunum using an IR camera (P=0.001).

5 HARMONIC FOCUS + Long Shears with Adaptive Tissue Technology Reliable, Safe, Fast HARMONIC ultrasonic technology Converts electrical energy to mechanical energy delivered via high-frequency vibrations No electricity transfer to, or through, the patient Blade vibrates 55,000 times per second to simultaneously seal and transect tissue HARMONIC devices with Adaptive Tissue Technology employ an advanced algorithm to continuously modulate energy delivery, providing critical thermal management Reliable sealing Seals 5 mm vessels, as well as lymphatics* Seal strength greater than 2X systolic blood pressure ( 200 mmhg) Less bleeding, less serous drainage 1 Procedure Outcome(s)1 Safety Significantly lower rate of: Intra-abdominal sepsis Wound complications With the HARMONIC FOCUS Long vs conventional hemostasis techniques used in right colectomies (in a prospective randomized clinical study). Axillary dissection Serous drainage volume reduced 37% Drain days reduced 43% Greater efficiency reduces operative time 2 Breast conserving surgery Drainage volume reduced 62.5% Drain days reduced 36% Procedure Reduction in operative time 2 Gastrectomy with lymphadenectomy Drainage volume reduced 41.4% Intraoperative blood loss reduced 34.3% Gastrectomy with lymphadenectomy Gastric cancer surgery 28 minutes 62 minutes Gastric cancer surgery # Estimated blood loss reduced 38% Hepatectomy ## 73 minutes Hepatectomy** Intraoperative blood loss reduced 55% Pancreatectomy *** 30 minutes Right Colectomy May decrease serous drainage volume Right Colectomy 28 minutes 1 Based on clinical studies using HARMONIC devices vs procedures using conventional techniques 2 Based on clinical studies using HARMONIC devices vs procedures using conventional techniques * Based on preclinical testing of blood vessels and lymphatic vessels up to and including 5 mm and 1 mm in diameter, respectively The burst pressure of transected 3-5 mm porcine carotids was mmhg at 99% probability and 95% confidence (n=89) Mean axillary drainage and mean drain days were 82.5 ml ( ) and 2.0 ( ) for HARMONIC FOCUS and ml ( ) and 3.5 ( ) for conventional surgery. Conventional surgery is defined as scissors in combination with monopolar and bipolar electrocautery. Böhm D, et al., Prospective randomized comparison of conventional instruments and the Harmonic Focus device in breast-conserving therapy for primary breast cancer. Eur J Surg Oncol Feb;38(2): Epub 2011 Dec 5. Mean breast drainage and mean drain days were 22.5 ml ( ) and 2.1 (±1.1) for HARMONIC FOCUS and 60.0 ml ( ) and 3.3 (±1.1) for conventional surgery. Conventional surgery is defined as scissors in combination with monopolar and bipolar electrocautery. Breast conserving surgery is lumpectomy or segmentectomy with removal of the tumor and sufficient normal breast tissue to ensure both tumor free specimen margins and a satisfactory cosmetic result. Böhm D, et al., Prospective randomized comparison of conventional instruments and the Harmonic Focus device in breast-conserving therapy for primary breast cancer. Eur J Surg Oncol Feb;38(2): Epub 2011 Dec 5. In a meta-analysis comparing HARMONIC devices to conventional techniques (P< ). Gastrectomy and D2 Lymphadenectomy for Gastric Cancer: A Meta-Analysis Comparing the Harmonic Scalpel to Conventional Techniques. Cheng, H et al. Volume 2015, Article ID , 11 pages. # In a prospective randomized study, patients with resectable adenocarcinoma of the stomach had a median blood loss of ml for ultrasonic and ml for conventional techniques (n=30 for each; P=0.016). Inoue K., et. al., Ultrasonic Scalpel for Gastric Cancer Surgery: a Prospective Randomized Study. J Gastrointest Surg (2012) 16:1840;1846. ** In a clinical study comparing HARMONIC devices to conventional techniques (P=.034). Skeletonization and Isolation of the Glissonean and Venous Branches in Liver Surgery With an Ultrasonic Scalpel Technology; Aoki, Takeshi et al; Int Surg 2015; 101: In a prospective randomized controlled clinical trial (n=211), using the HARMONIC FOCUS Long resulted in drainage volume at 1, 2, and 3 days after surgery (D1=125±40 ml, D2=70±3 ml, D3=50±20 ml) vs. conventional hemostasis (D1=155±50 ml, D2=110±35 ml, D3=80±40 ml) (P<0.05). Sista F, Abruzzese V, Schietroma M, et al. New Harmonic Scalpel vs. Conventional Hemostasis in Right Colon Surgery: a Prospective Randomized Controlled Clinical Trial. Dig Surg 2013; 30: Sista, F., et al. New Harmonic Scalpel versus Conventional Hemostasis in Right Colon Surgery: A Prospective Randomized Controlled Clinical Trial. Dig Surg 2013;30: In a meta-analysis comparing HARMONIC devices to conventional techniques (P=0.0002). Gastrectomy and D2 Lymphadenectomy for Gastric Cancer: A Meta-Analysis Comparing the Harmonic Scalpel to Conventional Techniques. Cheng, H et al. Volume 2015, Article ID , 11 pages. In a prospective randomized study that included patients with resectable adenocarcinoma of the stomach, median operation time for ultrasonic was mins and mins for conventional techniques (n=30 for each, P=0.0004). Inoue K., et. al., Ultrasonic Scalpel for Gastric Cancer Surgery: a Prospective Randomized Study. J Gastrointest Surg (2012) 16: ## In a clinical study comparing HARMONIC devices to conventional techniques (P=.001). Skeletonization and Isolation of the Glissonean and Venous Branches in Liver Surgery With an Ultrasonic Scalpel Technology; Aoki, Takeshi et al; Int Surg 2015; 101: *** In a retrospective analysis of data from 623 U.S. hospitals, use of the HARMONIC Technology in pancreatectomy procedures performed in 2008 resulted in a statistically significant mean time savings as compared to cut, clamp, and tie [6.9 hours vs. 7.4 hours (P= 0.022)]. In a prospective randomized controlled clinical trial (n=211), using the HARMONIC FOCUS Long resulted in a shorter average operative time vs. conventional hemostasis (103±21minutes, 131±27 minutes, respectively) (P<0.05). Sista F, Abruzzese V, Schietroma M, et al. New Harmonic Scalpel vs. Conventional Hemostasis in Right Colon Surgery: a Prospective Randomized Controlled Clinical Trial. Dig Surg 2013; 30:

6 The Advantage of Adaptive Tissue Technology in HARMONIC FOCUS + Long HARMONIC FOCUS + Long Shears with Adaptive Tissue Technology vs HARMONIC FOCUS Long Shears Improved Temperature Management with Adaptive Tissue Technology HARMONIC FOCUS + Long Shears with Adaptive Tissue Technology showed up to 13% cooler clamp arm temperature vs HARMONIC FOCUS Long Shears.* Benefits of Adaptive Tissue Technology Temperature With Adaptive Tissue Technology Without Adaptive Tissue Technology Improved Temperature Management Delivers energy intelligently Utilizes an advanced algorithm Responds to changing tissue conditions Provides enhanced audible feedback Enables greater surgical precision and performance Enhanced Audible Feedback Adaptive Tissue Technology results in significantly lower and more consistent temperatures. Time * Versus HARMONIC FOCUS Long shears without Adaptive Tissue Technology, as exhibited in a benchtop transection study on porcine jejunum using an IR camera (P<0.05). As compared to HARMONIC devices without Adaptive Tissue Technology Based on temperature and temperature variance of device following multiple transections using porcine jejunal tissue

7 Consider the Difference in Advanced Energy Devices HARMONIC FOCUS + Long Shears vs LigaSure LigaSure Atlas results in 27% hotter tissue temperature* Slimmer profile for improved visualization and precision in narrow spaces vs LigaSure Atlas and 5 mm Blunt Tip 33% wider jaw aperture than LigaSure 5 mm Blunt Tip, for greater versatility in dissection HARMONIC FOCUS + Long Shears vs Olympus THUNDERBEAT Olympus THUNDERBEAT results in 41% hotter tissue temperature 47% wider jaw aperture than Olympus THUNDERBEAT, for greater versatility in dissection Thermal comparison of HARMONIC FOCUS + Long Shears vs Olympus THUNDERBEAT and LigaSure Atlas HARMONIC FOCUS + Long Shears LigaSure Atlas Olympus THUNDERBEAT Thermascan comparison. The scale to the right of the images shows the temperatures range. Note the lower overall tissue temperature with the HARMONIC FOCUS + Long Shears vs the other devices. * Mean comparison (C ) in a benchtop study on 3-5 mm porcine carotid arteries via infrared camera, tissue temperature measured at distances of 2 mm lateral to device jaw Device measurements based on a metrology study (profile is defined as end effector distal width) Device measurements based on a metrology study. HARMONIC FOCUS + Long aperture measured inches and LIGASURE 5 mm Blunt Tip measured inches Mean comparison (C ) in a benchtop study on 3-5 mm porcine carotid arteries via infrared camera, tissue temperature measured at distances of 2 mm lateral to device jaw Device measurements based on a metrology study. HARMONIC FOCUS + Long aperture measured inches and Olympus THUNDERBEAT measured inches

8 Ethicon Endo-Surgery, Inc Creek Road Cincinnati, OH Product Code Description Quantity/Sales Unit HAR17F HARMONIC FOCUS+ Long Shears with Adaptive Tissue Technology 6 HARMONIC FOCUS + Long Shears is supplied sterile for single-patient use. It is compatible with existing Ethicon Generator G11 and HPBLUE Hand Piece. For complete product details, see Instructions for Use Ethicon Endo-Surgery, Inc. All rights reserved The third-party trademarks used herein are trademarks of their respective owners.