PROXISURE™ Suturing Device is the reusable suturing device featuring Ethicon's endomechanical, sutures and needle technologies that enables precise suturing in laparoscopic or minimally invasive procedures.

PROXISURE™ mimics the dexterity of the wrist through bidirectional 45-degree articulation, 360-degree rotation at the distal end, and a curved needle. It is designed to precisely suture and knot tie in tight spaces.

· Tight spaces and difficult angles can make precise suturing a challenge. PROXISURE™ enables precise suturing in tight spaces, which may lead to reduced OR time and cost.1-11

· PROXISURE Suturing Device enables surgeons to reach the angle. The device enables precise suture placement with minimal tissue manipulation.

· PROXISURE Suturing Device enables surgeons to control the bite. PROXISURE curved needle improves the surgeon's ability to suture a variety of tissue types, including flat surfaces, with less tissue manipulation, which results in less tissue trauma. PROXISURE promotes smoother tissue passed than Endo Stitch™ straight needle.

· PROXISURE Suturing Device enables surgeons to secure the knot. Sutures have predictable performance and superior characteristics versus competitor's sutures that allow surgeons to tie secure intracorporeal knots.2 Coated VICRYL® (polyglactin 910) Suture and ETHIBOND® Coated Polyester Suture have predictable performance and superior characteristics vs. competitor sutures resulting in excellent knot security.12-17

PROXISURE Suturing Device is designed to meet the needs of surgeons in procedures such as:

· Bariatric/General: Sleeve Gastrectomy, Gastric Bypass, Hiatal Hernia, and Nissen Fundoplication

· Gynecology: Hysterectomy, Myomectomy, Sacrocolpopexy

· Colorectal: Colectomy

References:

1. KosydarA_20160302_Design Science_Project Stitch Full Study_DOF_TR_20160302.pdf

2. ArnoldB_PRC075746_Ethicon_ProxiSure Suturing Device_DOF_BENCH_20160523.pdf

3. PRC073011B.pdf

4. PROXISURE_Suturing_Device_IFU_23MAR2016.pdf

5. PATTARAS_2001_JOURNAL OF ENDOUROLOGY_15_187 .pdf
Hart_2013_JSLS_17_508.pdf

6. Badawy_2012_IntUrolNephrol_44_769.pdf

7. Bermas_2004_JSLS_8_187.pdf

8. Harold_2002_SurgEndosc_16_1729.pdf

9. Nguyen_2000_J_Surgical_Research_93_133.pdf

10. PRC073685A.pdf

11. ArnoldB_PRC075746_Ethicon_ProxiSure Suturing Device_DOF_BENCH_20160523.pdf

12. Patsalos C, Karavias D, Stavropoulos M, et al. The relationship between five kinds of laparoscopic knots and five types of suture materials and histological findings in tissues: an experimental study on rabbits. Surg Laparosc Endosc Percutan Tech. 2003;13(3):202-207.

13. Ethicon, Inc.: Wound Closure Manual, 2012.

14. Rosin E, Robinson GM. Knot security of suture materials. Vet Surg. : VS. 1989;18(4):269-273.

15. van Leeuwen N, Trimbos JB. Strength of sliding knots in multifilament resorbable suture materials. Gynecol Surg. 2012;9(4):433-437.

16. Data on File, Ethicon, Inc.: Project Stitch - Knot Strength Testing for 510k. PRC073011.

17. Data on File, Ethicon, Inc.: Evaluation of physical and functional properties of size 2-0 ETHICON VICRL Plus, Syneture POLYSORB, and B Braun Novosyn Suture. AST-2013-02612.

Laparoscopic suturing remains one of the most challenging aspects of minimally invasive procedures (MIP), even though most surgeons who perform MIP feel adequate to confident in their skills. However, they miss the suturing precision they achieve in open procedures, especially in tight spaces.

Laparoscopic suturing, and specifically intra-corporeal knot tying, can be one of the more challenging aspects of performing minimally invasive procedures due to challenges associated with depth perception, tactile sense and visual obstruction make placing accurate and well-tied knots a difficult and time-consuming task. PROXISURE™ Suturing Device helps surgeons overcome these challenges.

PROXISURE™ Suturing Device's design strengths

Tight spaces and difficult angles can make precise suturing a challenge. PROXISURE™ Suturing Device offers an innovative alternative to traditional laparoscopic suturing and other devices that have been on the market for over a decade.

· PROXISURE enables precise suturing in tight spaces. Users can maneuver the needle and suture to reach target tissue from angles with 45-degree articulation, 360-degree rotation at the distal end, and a curved needle.

o Bi-directional articulating and rotating distal tip provides the 45-degree articulation and 360-degree rotation

o Reusable handle provides ergonomically positioned knobs to control rotation and articulation of the distal tip1

o Carefully positioned trigger auto-rotates the curved needle 180 degrees1

· PROXISURE Suturing Device enables precise suture placement with minimal tissue manipulation. It mimics the dexterity of the wrist for precise suturing and knot tying in tight spaces

· PROXISURE promotes smoother tissue passage than competitive devices and needles.

o The device's curved needle improves a surgeon's ability to suture a variety of tissue types, including flat surfaces, with less tissue manipulation resulting in less tissue trauma.

o The PROXISURE™ mechanical design passes the needle with a simple squeeze, resulting in the user needing less wrist turns and re-grasping of needle. Other laparoscopic suturing devices require frequently rotating and torqueing the wrist to approximate and pass a needle and suture through tissue.

o PROXISURE™ also manages the needle with all controls accessible by single handed use, as the needle is always held by the device to lessen the chance of dropping the needle in the surgical field.

PROXISURE offers earth-friendly choice

To improve the environmental performance of the manufacturer's products, Johnson & Johnson developed Earthwards®, a process that defines how the organization addresses the environmental and social impacts of its products, and engages development teams in designing innovative and more sustainable solutions. This unique program is helping to create a more sustainable world.

PROXISURE™ Suturing Device has been awarded the Earthwards® honor. This recognition acknowledges that PROXISURE™ Suturing Device has made significant sustainability improvements. It is a great achievement that demonstrates the combined efforts of an entire team to reduce the impacts of its products on the environment. A reusable handle offers an ergonomic, yet earth-friendly, design.

PROXISURE™ Suturing Device received Earthwards® recognition based upon the following improvements:

o Materials: 97% reduction in materials (excluding packaging) *

o Packaging: 99% reduction in secondary packaging *

o Energy: 5,200% reduction in required shipping space *

*Compared to previous disposable devices

References: 1. Data on file. Ethicon, Inc. ProxiSure IFU. 2. Data on file. Ethicon, Inc. Evaluation of physical and functional properties of size 2-0 Ethicon VICRYL Plus, Syneture Polysorb and B Braun Novosyn suture. AST-2013-0261. 2013.