Innovation that matters

AccuMesh™ Positioning System Accuracy Matters

| HERNIA CARE | MESH • FIXATION • Permacol™ • dissection

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AccuMesh™ Positioning System Accuracy Matters INTRODUCTION Success of a laparoscopic ventral repair is largely dependent on achieving a consistent 3–5 cm overlap between the edge of the mesh and the edge of the defect.1 With current techniques, accurately positioning the mesh is the most difficult mesh related step of the procedure.1 Covidien’s new AccuMesh™ positioning system with its expandable frame and precise articulation control is an innovative endomechanical device that facilitates insertion, deployment, and placement of Parietex™ Optimized Composite (PCOx) mesh.2 As a result, AccuMesh™ positioning system delivers superior accuracy and faster operative time compared to traditional laparoscopic ventral hernia repair methods.3

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AccuMesh™ Positioning System Accuracy Matters

CONSISTENT MESH OVERLAP For patients and surgeons, recurrence is one of the most concerning complications.1 Recurrence occurs mainly at the border of the mesh, indicating insufficient overlap thus the need to have a consistent mesh overlap of the defect is essential.1 Clinical Literature Review of Laparoscopic Approach1 Authors

n/N

Follow-up (mth) Overlap (cm) Recurrence

Authors

n/N

Follow-up (mth)

Overlap (cm)

Recurrence

Franklin

384

47.1

3-5

2.9%

Leblanc

200

36

3 vs ≥ 5

9% vs 4%

Bower

100

6.5

≥3

2%

Parker

50

3-74

4

0%

Heniford

850

20.2

≥3-5

4.7%

Jerabek

20

2-13

≥3

0%

Raftopoulos

50

NR

2-4

2.0%

Sharma

72

58

5

0%

Berger

150

15

3-5

2.7%

Topart

151/146

26.6

3-5

5.8%

Aura

86

37

≥3

7.0%

Tsimoyiannis

33 vs 47

51

≥2.5 vs ≥4

9% vs 2%§

Birgisson

64

1-35

4-5

0%

Asencio

45

12

3

9.75%

Sanchez

85

20

5

3.5%

Barbaros

23

18

≥3

0%

Carbalo

270

44

≥4

4.4%

Itani

73

24

≥3

12.5%

Bencini

50

14

5

2.0%

Misra

33

13.73

3-5

6%

Bageacu

177/159 49

3-5

11.9%

Navarra

12

6

5

0%

Gilian

100

1-60

≥3

1.0%

Olmi

85

24

4-5

2.3%

Kirshtein

103

26

3 vs ≥5

4.0%

Pring

31

27.5

3-4

3.3%

Kua

21

12

4

14.3%

Park

56

24.1

2.5

13.3%

Morales-Conde

140

40

≥3

2.14%

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AccuMesh™ Positioning System Accuracy Matters ACCURACY The ideal mesh placement is one with the hernia defect in the center of the mesh1:

Accurate Placement

consistent 3 to 5 cm Def overlap:

ect

Inaccurate Placement

Being just 1 cm off-center can increase recurrence up 14 percentage points

0% to 7% recurrence1 Images courtesy of Thieme Medical Publishers, Inc. COVIDIEN, COVIDIEN with logo, COVIDIEN logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. ™* Trademark of its respective owner. Other brands are trademarks of a Covidien company. © 2012 Covidien 11.12 M121087

Inconsistent overlap

9% to 14.3% recurrence1

AccuMesh™ Positioning System Accuracy Matters

THE ISSUE WITH ACCURACY Accurately centering the mesh over the defect can be challenging and time consuming.4 One contributing factor is that of “mesh shift” which occurs in 48% of traditional lap ventral hernia repairs. Mesh shift is defined as when the mesh is off-center relative to the defect. 4 Furthermore, 92% of the time the mesh was pushed away from the ports likely due to tacking and the tendency to push the mesh away from the operator. 4 Ideal mesh placement versus mesh shift.

A fa s c i a

skin

mesh

Ideal mesh placement; the mesh has equal overlap on the right and left abdominal fascia

B fa s c i a

skin

mesh

Mesh shift with unequal overlap

Accurately placing the mesh relative to the defect is the most difficult step

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AccuMesh™ Positioning System Accuracy Matters PRODUCT FEATURES 100 degrees of articulation to center mesh over defect Living hinge to align mesh to the abdominal wall Compatible with Parietex™ Optimized Composite Mesh

High visibility orange marking indicates center of mesh4

Articulation Knob

Expanding frame for fast, easy mesh deployment4 Deployment Slider Mesh Release Lever

Ergonomic Handle

Superior accuracy and faster operative time3 compared to traditional mesh placement methods.

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AccuMesh™ Positioning System Accuracy Matters PRODUCT BENEFITS

Superior Accuracy3

Faster Operative Time3

• Statistically significant improvement in accuracy of mesh placement†,3 • 85% of surgeons improved accuracy compared to their previous technique†,3 • Improving accuracy may decrease recurrences by up to 14 percentage points1

• Statistically significant reduction in mesh related OR time by more than 40%†,3 • 100% of surgeons reduced their mesh related OR time†,3 • Fewer procedural steps than Bard Echo PS2,6

Time Savings (%)

Minimum Overlap (cm) 3.80

80%

3.70

70%

3.60

60%

3.50 3.40

50%

3.30

40%

3.20

Time Savings (%)

3.10 3.00 80%

Current Overlap

Time Sa

30% 20%

AccuMesh™ Overlap

10%

70%

40% Time Savings (%)

30% † Compared to current technique, measured in an inanimate lab. Data on file. 20% 10%

12 n eo

11 n eo

10 n eo

9 ge

on

8 ge

on

7 on

6 ge

on

5 ge

on ge

on

4

3 ge

ge

on

2 ge

on

1 on ge

AG

E

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R

n

12

11

eo

Su rg

n

Su rg e

eo

Su rg

on

10

9 n

8

rg eo Su

n

7

rg eo Su

n

6

rg eo Su

n

5

rg eo

n Su

rg eo

Su

on

4

3 n

Su rg e

rg eo

n Su

rg eo Su

n

1

E Su

rg eo

AV ER AG

50%

2

0%

60%

AccuMesh™ Positioning System Accuracy Matters PRODUCT BENEFITS

Easy to Use7 • Easy to attach, roll, insert, deploy, position and fixate the mesh7 • Eliminates the need for laparoscopic manipulation of the mesh2 • Fits through a smaller trocar than Bard Echo PS6

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AccuMesh™ Positioning System Accuracy Matters

COMPETITIVE COMPARISON Covidien AccuMesh™ Positioning System with Parietex™ Optimized Composite Mesh2

≠

Positioning System

•

Hydrophilic Mesh

•

Macroporous

•

Defined Parietal and Visceral Side

•

Articulation Control

•

Preserves Skin Over Defect

•

Reduces OR Time

•

Fewer Procedural Steps≠

•

Improves Accuracy

•

Fits Down Standard 12 mm Trocar

•

Ancillary Device to Aid Insertion

•

BARD Echo PS™* with Composix™* or Ventralight™*,6,8

BARD Composix™* Ethicon Physiomesh™*,13,14 or Ventralight™*,9,10,11,12

• • •

• N/A •

Based on positioning system steps

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• •

•

N/A

N/A

N/A

N/A

N/A

N/A

•

•

AccuMesh™ Positioning System Accuracy Matters

REIMBURSEMENT INFORMATION15 Code Type

Code

Description

Physician

Hospital Outpatient

ASC

CPT

49652

Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia (includes mesh insertion, when performed); reducible

$683.82

$5,010.75

$2,887.73

CPT

49653

Laparoscopy, surgical, repair, ventral, umbilical, spigelian or epigastric hernia (includes mesh insertion, when performed); incarcerated or strangulated

$854.00

$5,010.75

$2,887.73

CPT

49654

Laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed); reducible

$776.74

$5,010.75

$2,887.73

CPT

49655

Laparoscopy, surgical, repair, incisional hernia (includes mesh insertion, when performed); incarcerated or strangulated

$948.29

$5,010.75

$2,887.73

CPT

49656

Laparoscopy, surgical, repair, recurrent incisional hernia (includes mesh insertion, when performed); reducible

$839.71

$5,010.75

$2,887.73

CPT

49657

Laparoscopy, surgical, repair, recurrent incisional hernia (includes mesh insertion, when performed); incarcerated or strangulated

$1,205.95

$5,010.75

$2,887.73

ICD 9 cm Procedure

53.62

Laparoscopic incisional hernia repair with graft or prosthesis

See DRG

Possible MS-DRG Classification MS-DRG

353

Hernia procedures except inguinal & femoral w MCC

$16,278.77

MS-DRG

354

Hernia procedures except inguinal & femoral w CC

$9,224.94

MS-DRG

355

Hernia procedures except inguinal & femoral w/o CC/MCC

$6,450.99

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Note: No MS-DRG differentiation between Lap and Open in Inpatient Procedures

AccuMesh™ Positioning System Accuracy Matters

COMPETITIVE CROSS-REFERENCE Covidien AccuMesh™ Positioning System

BARD Ventralight™* ST

AMPPCO15X 5954600 AMPPCO2015X 5954680 AMPPCO20X

5954790

Composix™* L/P

Ethicon

Ventralight ST™* with Echo PS™* Composix™* L/P with Echo PS™* PhysioMesh™*

134450

PHY1015V

134460

PHY1515Q

134480

PHY1520R

134490

5955680

144680

PHY1520V

5955790

144790

PHY2025V

5954800

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AccuMesh™ Positioning System Accuracy Matters

PACKAGING INFORMATION Inner Components •

PCOx Mesh

• • •

AccuMesh™ Device Furling Sleeve Mesh Attachment Device (MAD)

Outer Box

AccuMesh™ Positioning System L - 30 and 11/16 W -12 and 11/16 H - 3 and 11/16

LVHR kit with 5 devices included •

Endo Close™

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AccuMesh™ Positioning System Accuracy Matters

TECHNICAL INFORMATION

Technical Specifications7 Mesh Textile

Polyester

Mesh Barrier

Collagen and Glycerol

Mesh Pore Size (mm) (height x width)

2.4 x 2.0

Macropore* (mm) (height x width)

4.8 x 2.0

Mesh Thickness

1.7

Mesh Surface Density

78

Mesh Burst Strength

367 ± 20

Mesh Burst Distension

8±0

Mesh Sterilization

Gamma

AMP Sterilization

ETO

Trocar Size

12 mm

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AccuMesh™ Positioning System Accuracy Matters

ORDERING INFORMATION Code

AMP Frame Size

PCOx Mesh Size

AMPPCO15X

Medium

15 cm round

AMPPCO2015X

Medium

20 x 15 cm

AMPPCO20X

Medium

20 cm round

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Packaging

AccuMesh™ Positioning System Accuracy Matters

INSTRUCTIONS FOR USE AccuMesh™ Articulating Mesh Positioning Device 1304208   BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY. CONTRAINDICATIONS The device is not intended for use with access ports less than 10mm in size. WARNINGS AND PRECAUTIONS 1. Please read all instructions before using the AccuMesh™ articulating mesh positioning system. 2. The AccuMesh™ articulating mesh positioning system is provided sterile and intended for single use only – DISCARD AFTER USE. DO NOT RESTERILIZE. 3. If package is damaged or open, do not use product. Check package for damage prior to use. DESCRIPTION The AccuMesh™ articulating mesh positioning system is a single use laparoscopic surgical device which is intended to fa4. Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic cilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. The surgeon connects a standard hernia technique. mesh to the AccuMesh™ articulating mesh positioning system by using the supplied mesh attachment device. Following the 5. After use, the AccuMesh™ articulating mesh positioning system may become a potential biohazard. The system has 8 attachment of the mesh, the mesh is rolled up on the device using the mesh furling tool and inserted into the abdominal clips located at the deployment section which must be regarded as sharp. Handle and dispose of in accordance with any cavity through a standard laparoscopic port (trocar). Once inside the abdominal cavity, the AccuMesh™ articulating mesh local and federal laws regarding medical waste and sharps disposal requirements to prevent sharps injuries. positioning system enables the surgeon to rapidly deploy and place the mesh over the defect. The mesh is anchored to 6. Do not place your hands or fingers on or near the connection clips. the abdominal wall by conventional technique (e.g., tacks, sutures); upon mesh fixation the mesh is released from the Ac- 7. Verify the mesh and deployment frame is placed within the profile of the furling tool. cuMesh™ articulating mesh positioning system and removed from the abdominal cavity through the access port (trocar). 8. Verify that the entire deployment section is inside the abdominal cavity and past the distal end of the access port before deploying the mesh. INDICATIONS CAUTION: During device closing and extraction, follow the tip and the frame of the AccuMesh™ articulating mesh posiThe AccuMesh™ articulating mesh positioning system is intended to facilitate delivery and placement of soft tissue prostioning system using the laparoscopic camera in order to avoid contact with any internal organs. thetics during laparoscopic repair of soft tissue defects. (e.g., hernia repair). AVOID PROLONGED EXPOSURE TO ELEVATED TEMPERATURES. IMPORTANT! This booklet is designed to assist in using this product. It is not a reference to surgical techniques. This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or re-sterilization of this device may create the risk of contamination and patient infection. Do not reuse, reprocess or re-sterilize this device.

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AccuMesh™ Positioning System Accuracy Matters

INSTRUCTIONS FOR USE Operating Steps

1. Place mesh with the visceral side down and parietal side up onto the deployment frame. The blister will have a recess that will accept the mesh and automatically position the mesh to the center of the frame. CAUTION: Do not place your hands or fingers on or near the connection clips.

2. Close frame until audible click is heard. The frame is now locked in the closed position.

3. Depress the (2) lateral thumb tabs on the frame to engage the mesh onto the deployment frame.

4. Lift the upper frame to remove the device from the blister package. Remove the system from the blister package by grasping the handle and lifting upward.

5. Refer to mesh IFU for specific instruction for mesh preparation, i.e., hydration requirements if needed.

6. Close the deployment frame with attached mesh by pushing the deployment lever away from the handle body until it stops.

7. Open the furling tool and place the prepared mesh and deployment frame into the furling tool. CAUTION: Verify the mesh and deployment frame is placed within the profile of the furling tool.

8. The mesh is rolled by rotating the handle of the AccuMesh™ articulating mesh positioning system and simultaneously closing the furling tool with hand pressure to achieve a tight roll of the mesh prior to insertion into the access port and abdominal cavity.

9. Insert the furling tool into the access port.

10. Push and rotate the mesh into the access port.

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AccuMesh™ Positioning System Accuracy Matters

INSTRUCTIONS FOR USE Operating Steps

11.Remove the insertion tool.

12. Push and rotate the mesh into the abdominal cavity under visualization. CAUTION: Verify that the entire deployment section is inside the abdominal cavity and past the distal end of the access port before deploying the mesh.

13. Deploy the mesh by pulling back on the deployment lever until it stops against the handle body. CAUTION: Verify that the mesh is unfurled by gently shaking the device or if convenient, by using a grasper prior to deploying the mesh.

14. If necessary, rotate the mesh utilizing the articulation knob until it is correctly oriented with respect to the hernia defect.

15. Elevate mesh over the defect until the mesh is substantially adjacent to the tissue. NOTE: If necessary correct the location and the orientation by slightly lowering the device with the mesh attached, adjusting its location and elevating it back up to the hernia site.

16. Fixate the mesh to the abdominal wall with at least 8 hernia tacks around the outer perimeter of the mesh while holding the AccuMesh™ articulating mesh positioning system in place. CAUTION: Do not move the AccuMesh™ articulating mesh positioning system during mesh fixation in order to maintain a fully spread mesh.

17. Remove and discard the mesh detachment lock then pull back the mesh detachment lever on the handle.

18. Lower the device until it is fully separated from the mesh.

19. Close the deployment frame by pushing the deployment lever away from the handle body until the deployment section is fully closed.

20. Extract the device out of the abdominal cavity through the access port.

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AccuMesh™ Positioning System Accuracy Matters 510K

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AccuMesh™ Positioning System Accuracy Matters REFERENCES 1

Clinical Literature Review. Mesh overlap and risk of recurrence in ventral hernia mesh repair. Jan 2012. Data on file Covidien

­ AccuMesh™ IFU 2 3

Covidien Internal Engineering Test Report R2138-078-02

4

Liang, M., Clapp, M., Garcia, A., Subramanian, A., Awad, S. Mesh shift following laparoscopic ventral hernia repair. Journal of Surgical Research 177 (2012) E7-E13

5

Covidien Market Research Oct. 2011

6

Bard Echo PS™* IFU

7

Product Specification

8

Bard Echo PS™* Marketing Materials 2012 http://www.davol.com/products/soft-tissue-reconstruction/hernia-repair/ventral-hernia-repair/laparoscopic-repair-options/echo-ps/

9

Bard Composix™* IFU Bard Composix™* Marketing Materials 2012 http://www.davol.com/products/soft-tissue-reconstruction/hernia-repair/ventral-hernia-repair/laparoscopic-repair-options/composix-lp-mesh/

10

Bard Ventralight™* IFU

11

Bard Ventralight™* Marketing Materials 2012 http://www.davol.com/products/soft-tissue-reconstruction/hernia-repair/ventral-hernia-repair/laparoscopic-repair-options/ventralight-st-mesh/

12

Ethicon Physiomesh™* IFU

13

Ethicon Physiomesh™* Marketing Materials October 2012 http://www.ethicon360.com/products/ethicon-physiomesh

14

CMS website www.cms.gov

15

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