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1 Preclinical perfusion model comparing Ethicon CDH29P to Medtronic manual EEA2835, in which perfusion was not statistically significantly different between devices (p>0.005). Ethicon, PSB004557 A comparison of staple line perfusion between 29mm ECHELON CIRCULAR™ Powered Stapler (CDH29P) and manual 28mm DST Series™ EEA™ Circular Stapler (EEA2835), November 2016, Data on File (063163-161111) 2 Benchtop testing in porcine tissue at 30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic (Covidien) manual EEA2835, p<0.001. Ethicon, PRC077848 Leak Claims Testing, October 2016, Data on File (063159-170816) Echelon Circular Claims compared to the Medtronic manual DST Series™ EEA™ Stapler. Based on benchtop testing. Optimised perfusion 1 . Reduced leaks at the staple line 2 . ECHELON CIRCULARPowered Stapler 61 1 When compared vs Medtronic compared to the Medtronic DST Series™ EEA™ Stapler. at the staple line
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Optimised perfusion1. Reduced leaks at the staple line2.

May 02, 2023

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Page 1: Optimised perfusion1. Reduced leaks at the staple line2.

1 Preclinical perfusion model comparing Ethicon CDH29P to Medtronic manual EEA2835, in which perfusion was not statistically significantly different between devices (p>0.005). Ethicon, PSB004557 A comparison of staple line perfusion between 29mm ECHELON CIRCULAR™ Powered Stapler (CDH29P) and manual 28mm DST Series™ EEA™ Circular Stapler (EEA2835), November 2016, Data on File (063163-161111)

2 Benchtop testing in porcine tissue at ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic (Covidien) manual EEA2835, p<0.001. Ethicon, PRC077848 Leak Claims Testing, October 2016, Data on File (063159-170816)

Echelon Circular™Claims compared to the Medtronic manual DST Series™ EEA™ Stapler.

Based on benchtop testing.

Optimised perfusion1. Reduced leaks at the staple line2. ECHELON CIRCULAR™ Powered Stapler

61

1

When compared vs Medtronic compared to the Medtronic DST Series™ EEA™ Stapler.

at the staple line

Page 2: Optimised perfusion1. Reduced leaks at the staple line2.

Designed for creating a secure anastomosis

Your goal: the best stapling outcomes even in the most challenging cases

Tissue tension, poor blood supply and variable tissue thickness can compromise the anastomosis and lead to significant complications. Among complications, anastomotic leaks are a dominant surgical concern due to their high mortality risk.

Two technologies only in the ECHELON CIRCULAR™ Powered Stapler

The cause of anastomotic leaks is multi-factorial, including both patient and surgical factors. With two technologies, the ECHELON CIRCULAR Powered Stapler has been designed to address device-to-tissue interaction and device-to-user interaction to reduce leaks at the staple line without compromising perfusion.1

Up to

4%of gastrectomies3

Up to

11%of esophagectomies4

Anastomotic leak rates

Up to

12%of colorectal resections2

1 Benchtop testing in porcine tissue ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic (Covidien) manual EEA2835 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices. Ethicon, PRC077848 Leak Claims Testing, October 2016, Data on File. Ethicon, PSB004557 A comparison of staple line perfusion between 29mm ECHELON CIRCULAR™ Powered Stapler (CDH29P) and manual 28mm DST Series™ EEA™ Circular Stapler (EEA2835), November 2016, Data on File (063164-170816)

2 Koianka T, Kevin M, Martin W, et al. Identifying Important Predictors for Anastomotic Leak After Colon and Rectal Resection. Annals of Surgery. 2013; 257: 108

3 Oh SJ, Choi WB, Song J. et al. Complications requiring reoperation after gastrectomy for gastric cancer: 17 years experience in a single institute. J Gastrointest Surg. 2009; 13:239

4 Kassis E, Kosinski A, Ross P, et al. Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg. 2013; 96:1919

Claims compared to the Medtronic manual DST Series™ EEA™ Stapler. Based on benchtop testing.

Page 3: Optimised perfusion1. Reduced leaks at the staple line2.

Combining technologies to reduce leaks

3D Stapling Technology

• Designed with offset closure of the staple legs,3D Stapling Technology can evenly distributecompression throughout the anastomosis.1

• Can reduce potential leak paths.1

Gripping Surface Technology

• Atraumatic Gripping Surface Technology givesprecise compression only where it is needed2to prepare the tissue for staple formation.

• Can provide gentler handling with a 33% reductionin compressive forces on tissue.2

Powered firing platform

• Push button firing has delivered 37% lessmovement at the distal tip for increasedstability3

• Has reduced force to fire by 97%4

• Is designed to help minimise variation in usageand standardise performance across users5

Ethicon ECHELON CIRCULAR™

3D Stapling Technology

Illustration depicts actual paths of tip movement during testing— each cube represents a space measuring 5mm3

Medtronic DST Series™ EEA™

2D Stapling

Conceptual comparison demonstrating potential effects of tissue compression during firing. Results can vary based on tissue characteristics, device design, techniques and other factors.

Conceptual comparison demonstrating potential effects of tissue compression during firing. Results can vary based on tissue characteristics, device design, techniques and other factors.

1 Staple line analysis in benchtop testing, comparing Ethicon CDH25P to Medtronic manual. Ethicon, PRC078258 Even Compression Claims Testing, November 2016, Data on File (063169-170314)

2 Benchtop testing on porcine colon, comparing Ethicon CDH29P to Medtronic manual, p<0.001. Ethicon, PRC078621 Echelon Powered Circular Gentler Handling Test Completion Report, January 2017, Data on File (065619-170117)

3 Users firing in a porcine model, comparing Ethicon CDH29P to Medtronic manual, p=0.003. Ethicon, PRC078105 Distal Tip Movement Claims Testing, November 2016, Data on File (063167-161111)

4 Benchtop testing, comparing Ethicon CDH29P to Medtronic manual, p=0.001. Ethicon, PRC078173 Reduced Force to Fire Claims Study, November 2016, Data on File (063168-161111)

5 Ethicon, E844 Summary of Design intent for ECHELON CIRCULAR Powered Stapler to support claims, November 2016, Data on File (063173-161111)

Claims compared to the Medtronic manual DST Series™ EEA™ Stapler. Based on benchtop testing.

Page 4: Optimised perfusion1. Reduced leaks at the staple line2.

Contact your local Ethicon sales representative for more information.

A stapling solution that can optimise perfusion and reduce leaks at the staple line1

1 Benchtop testing in porcine tissue ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic (Covidien) manual EEA2835 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices. Ethicon, PRC077848 Leak Claims Testing, October 2016, Data on File. Ethicon, PSB004557 A comparison of staple line perfusion between 29mm ECHELON CIRCULAR™ Powered Stapler (CDH29P) and manual 28mm DST Series™ EEA™ Circular Stapler (EEA2835), November 2016, Data on File (063164-170816)

Claims compared to the Medtronic manual DST Series™ EEA™ Stapler. Based on benchtop testing.

The ECHELON CIRCULAR Powered Stapler is designed for creating the anastomosis in colorectal, gastric and esophagectomy procedures. An innovative combination of technologies enables you to reduce leaks without compromising perfusion.1

61 1

When compared vs Medtronic compared to the Medtronic DST Series™ EEA™ Stapler.

at the staple line

Page 5: Optimised perfusion1. Reduced leaks at the staple line2.

Better leak prevention at the staple line

The ECHELON CIRCULAR™ Powered Stapler reduce leaks by 61% at the staple line compared to the Covidien (Medtronic) DST Series™ EEA™ Stapler.1

• 3D Stapling Technology evenly distributes compression2

• Gripping Surface Technology provides gentler handling which has resulted ina 33% reduction in compressive forces on tissue3

• The combination of 3D Stapling Technology and Gripping Surface Technologycan optimise perfusion and reduce leaks at the staple line1

Built on a powered firing platform, the ECHELON CIRCULAR Powered Stapler can lead to 37% less movement at the distal tip for increased stability.4

3D Stapling Technology

(2 rows)

2D Stapling Technology

(2 rows)

3D StaplingTechnology

Gripping Surface Technology

1 Benchtop testing in porcine tissue ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon CDH29P to Medtronic (Covidien) manual EEA2835 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices. Ethicon, PRC077848 Leak Claims Testing, October 2016, Data on File. Ethicon, PSB004557 A comparison of staple line perfusion between 29mm ECHELON CIRCULAR™ Powered Stapler (CDH29P) and manual 28mm DST Series™ EEA™ Circular Stapler (EEA2835), November 2016, Data on File (063164-170816)

2 Staple line analysis in benchtop testing, comparing Ethicon CDH25P to Medtronic manual. Ethicon, PRC078258 Even Compression Claims Testing, November 2016, Data on File (063169-170314)

3 Benchtop testing on porcine colon, comparing Ethicon CDH29P to Medtronic manual, p<0.001. Ethicon, PRC078621 Echelon Powered Circular Gentler Handling Test Completion Report, January 2017, Data on File (065619-170117)

4 Users firing in a porcine model, comparing Ethicon CDH29P to Medtronic manual, p=0.003. Ethicon, PRC078105 Distal Tip Movement Claims Testing, November 2016, Data on File (063167-161111)

Claims compared to the Medtronic manual DST Series™ EEA™ Stapler. Based on benchtop testing.

Page 6: Optimised perfusion1. Reduced leaks at the staple line2.

ECHELON CIRCULAR™ Powered Stapler

CODE DIAMETER QUANTITY PER SALES UNIT

CDH23P 23mm 3

CDH25P 25mm 3

CDH29P 29mm 3

CDH31P 31mm 3

Please always refer to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.

The third-party trademarks used herein are the property of their respective owners.

Johnson & Johnson Medical Limited Baird House

4 Lower Gilmore BankEdinburgh

EH3 9QP

© Johnson & Johnson Medical Limited 2018, 086246-171221 UK

Claims compared to the Medtronic manual DST Series™ EEA™ Stapler. Based on benchtop testing.