Enseal™

ENSEAL™ X1 Tissue Sealers Expect more.

E N S E A L ™ X 1 L A R G E J AW

E N S E A L ™ X 1 C U RV E D J AW

The ENSEAL™ X1 Tissue Sealers are advanced bipolar devices

designed for use in open or laparoscopic surgical procedures.*

They have been completely redesigned to provide secure sealing

with more intuitive, simplified steps-for-use.

The ENSEAL™ X1 Tissue Sealers offer more than LigaSure™

More efficient2

More secure1

* ENSEAL™ X1 Large Jaw is intended for use in open surgical procedures

1. Preclinical test of distal tip bleeding (ENSEAL™ vs. Impact-LF4318) in thick porcine mesentery base (p=0.001). (093443-180612). 2. Based on metrology data, ENSEAL™ X1 Curved Jaw Tissue Sealer has a 16% (or 3.4mm) longer jaw than LigaSure™ Maryland (LF1937) (p < 0.001) and ENSEAL™ X1 Curved Jaw Tissue Sealer has a 40% (or 5.0mm) wider unbiased jaw aperture than LigaSure™ Maryland (LF1937) (p < 0.001). (093766-180619).

• Can capture more tissue per bite with a longer jaw and wider jaw aperture1

• 37% higher average grasping force compared to LigaSure™ Maryland2

• 360° continuous shaft rotation to enable easy access to targeted tissue3

More efficient than LigaSure™ Maryland1

ENSEAL™ X1 Curved Jaw Tissue Sealer

ENSEAL X1 Curved Jaw LigaSure™ Maryland

REFERENCES: 1. Based on metrology data, ENSEAL™ X1 Curved Jaw Tissue Sealer has a 16% (or 3.4mm) longer jaw than LigaSure™ Maryland (LF1937) (p < 0.001) and ENSEAL™ X1 Curved Jaw Tissue Sealer has a 40% (or 5.0mm) wider unbiased jaw aperture than LigaSure™ Maryland (LF1937) (p < 0.001). (093766-180619). 2. ENSEAL™ X1 Grasping Claims Testing Report shows grasping force measured as the maximum amount of force required to pull a thin strip of chamois, simulating a piece of tissue, from device jaws. Comparison of Enseal™ X1 Curved Jaw to LigaSure™ Maryland (LF1937) (p < 0.001). (094203-180628). 3. ENSEAL™ X1 Tissue Sealers IFU. (093778-180619). 4. Floyd Claims Industrial Design Memo. (095323-180718). 5. Metrology report comparing the jaw aperture of Enseal™ X1 Curved Jaw to LigaSure™ Maryland (LF1937) (p < 0.001). (093777-180619). 6. Metrology report comparing ENSEAL™ X1 Curved Jaw to LigaSure™ Maryland (LF1937) (p < 0.001). (093771-180619, 093769-180619). 7. Metrology report comparing ENSEAL™ X1 Curved Jaw to LigaSure™ Maryland (LF1937) (p < 0.001). (093771-180619, 093769-180619).

ENSEAL™ X1 Curved Jaw can capture more tissue per bite with a longer jaw and wider jaw aperture compared to LigaSure™ Maryland1

Curved, tapered tip designed for fine dissection4

6

7

5

More secure than LigaSure Impact™1

• Enables better sealing with less bleeding at the distal tip1

• Had 41% less lateral thermal spread2

• Has a improved design with convenient controls and 360° rotation3

ENSEAL™ X1 Large Jaw Tissue Sealer

ENSEAL™ X1 Large Jaw LigaSure Impact™ ENSEAL™ X1 Large Jaw

1. Preclinical test of distal tip bleeding (ENSEAL™ vs. Impact-LF4318) in thick porcine mesentery base (p=0.001). (062628-180228). 2. Preclinical testing on porcine carotids (ENSEAL™ vs. Impact-LF4318) that measured mean max lateral thermal damage via histology (p=0.005). (062746-180228). 3. (093778-180619) 4. Internal engineering assessment of end effector seal area. (062722-161103).

With a larger distal electrode surface area,4 ENSEAL X1 Large Jaw had significantly less bleeding at the distal tip vs LigaSure Impact™ in thick tissue1

Expect more with ENSEAL™ X1 devices

Intelligent energy delivery

Surgeon

Tissue Changes

Device ENSEAL® X1

Device

The Intelligence of Adaptive Tissue Technology

Ethicon GEN11 Generator

Seal vessels up to and including 7 mm and lymphatics3

Vessels sealed with ENSEAL™ X1 Curved Jaw Tissue Sealer had an average burst pressure of more than 10x normal systolic4

Silicone-coated jaws to reduce tissue sticking5

Advancing beyond secure sealing

The Intelligence of Adaptive Tissue Technology

Adaptive Tissue Technology, powered by the Ethicon GEN11 Generator, uses an advanced algorithm

for intelligent and efficient energy delivery. In ENSEAL™ X1 devices, it continuously:

• Senses changes in tissue and device conditions

• Responds with the optimal amount of energy

1. In a preclinical study on porcine carotid arteries, average thermal spread measured via histology was 1.6mm (95% CI: 1.27 – 1.95mm). (095310-180718). 2. Preclinical testing on porcine carotids that measured mean max lateral thermal damage via histology (mean=1.57mm). (062963-161108). 3. (093781-180619) 4. In benchtop testing on 4-7mm porcine carotid arteries, average burst pressure was 1274 mmHg. (094360-180702). 5. (095690-180724)

ENSEAL™ X1 Curved Tissue Sealers

produce minimal lateral thermal spread (~1.6 mm)1,2

ENSEAL™ X1 Device

Enseal™

• Intuitive design1 with separate seal and cut functionality1

• Conveniently placed control buttons designed for less hand movement1

• 360° shaft rotation designed to improve access to targeted tissue2

ENSEAL™ X1 devices feature ergonomic engineering

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. Ethicon Endo‐Surgery (Europe) GmbH Hummelsbütteler Steindamm 71 22851 Norderstedt, Germany

© Ethicon Endo-surgery (Europe) GmbH 2019, 103873-181210 EMEA

1. Industrial Design Report. (095687-180724, 093782-180619, 095686-180724). 2. ENSEAL™ X1 Tissue Sealers IFU. (093778-180619).

How to order

Please contact your Ethicon Sales Representative.

Customer support Visit www.ENSEAL.com/X1 for more information about the ENSEAL X1 Tissue Sealers.

DESCRIPTION PRODUCT CODE SHAFT LENGTH (cm) SHAFT DIAMETER (mm) QUANTITY/SALES UNIT

ENSEAL™ X1 Curved Jaw NSLX125C 25 5 3

ENSEAL™ X1 Curved Jaw NSLX137C 37 5 3

ENSEAL™ X1 Curved Jaw NSLX145C 45 5 3

ENSEAL™ X1 Large Jaw NSLX120L 20 13 6

• ENSEAL™ X1 Curved Jaw and ENSEAL™ X1 Large Jaw are supplied sterile for single-patient use

• Both devices are compatible with the Ethicon GEN11 Generator (software version 2016-1 or later versions)