Natural Suturability & Compliance

AV ACCESS

ML0951.000 (06/2015)

Table of Contents

• Background: AV Grafts• Xenografts• ProCol Patient Candidates• ProCol Clinical Data• ProCol Benefits• ProCol Product Information

Background: AV Grafts

• Numerous alternative conduits have been used for AV access including polyester, ePTFE, bovine carotid artery, and cryopreserved femoral vein and artery.1

1. Cronenwett and Johnston. Rutherford’s Vascular Surgery. 8th Ed. Vol 2. 1402- 30. Elsevier Saunders. Philadelphia, PA.

Xenograft Options

1. Katzman HE. Bioprostheses for Hemodialysis Access and Clinical Applications of the ProCol® Graft. Presented at VEITH SYMPOSIUM Nov 2007; New York, NY. 2. Woodhouse KA, Klement P, Chen V, et al. Investigation of recombinant human elastin polypeptides as non-thrombogenic coatings. Biomaterials 2004; 4543-4553. 3. Artegraft Instructions for Use, 1450240 Rev. J, 1992. Downloaded on 4/22/2015 at http://artegraft.com/Documents/PDFs/Products/Artegraft_Instructions-for-Use.pdf 20.

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1

2

31

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Patient Candidates

• Redo Patients with Failed AV Graft Who Require a New Access1-8

• Hypercoagulable Patient History:3,4,8,9

- Lupus patients8

• Patients with High Risk of Infection:10

- Thigh AV graft access1,6

- Patients under immunosuppression10

- Patients with rashes or prior graft infections10

• Patients Requiring Salvage of Existing Access:11

- Insufficient autologous tissue available11

• Graft Compliance at Anastomosis: - Patients who require a compliant graft at the anastomosis (e.g. young, thin or elderly female patients)12

1. Glickman, et al. Multicenter Results of Using a Mesenteric Vein Bioprosthesis (ProCol®) as a Conduit for Hemoaccess in Patients with Multiple ePTFE Grafts Placed in the Leg. 29th Global Vascular and Endovascular Issues, Techniques and Horizons. 2002. 2. Katzman, et al. Multicenter Evaluation of the Bovine Mesenteric Vein Bioprosthesis for Hemodialysis Access in Patients with an Earlier Failed Prosthetic Graft. J Am Coll Surg 2005; 201:223-230. 3. Katzman HE. Bioprostheses for Hemodialysis Access and Clinical Applications of the ProCol® Graft. Presented at VEITH SYMPOSIUM Nov 2007; New York, NY. 4. Glickman MH, et al. Challenges of hemodialysis access for high risk patients: Impact of mesenteric vein bioprosthetic graft. J Vasc Access 2003; 4:73-80. 5. Gensler TW, Stout CL, Glickman MH. Grafts are Superior to Basilic Vein Transposition Arteriovenous Fistulae. Presented at VEITH SYMPOSIUM Nov 2008; New York, NY. 6. Glickman MH, Katzman HE, Lawson JH. To Thigh Or Not To Thigh, Should a Prosthetic Graft Be Placed?. In: Henry ML, Ed. Vascular Access for Hemodialysis-IX. Los Angeles CA: Bonus Books, Inc.; 2005; 219-228. 7. Bernik TR. ProCol® Mesenteric Vein Graft for Difficult AV Access. Presented at VEITH SYMPOSIUM 2005; New York, NY. 8. Gray, et al. Evaluation and Management of Hypercoagulability in Vascular Access Patients. 29th Global Vascular and Endovascular Issues, Techniques and Horizons. 2002. 9. O’Shea, et al. Hypercoagulable states and antithrombotic strategies in recurrent vascular access site thrombosis. J Vasc Surg 2003; 38:541-8. 10. Tahami, et al. Polytetrafluoroethylene and bovine mesenterial vein grafts for hemodialysis access: a comparative study. J Vasc Access 2007; 8:17-20. 11. Benedetto, et al. Use of bovine mesenteric vein in rescue vascular access surgery. J Vasc Access 2010; 11:112-114. 12. Data on File.

1. Katzman HE, Glickman MH, Schild AF, et al. Multicenter Evaluation of the Bovine Mesenteric Vein Bioprosthesis for Hemodialysis Access in Patients with an Earlier Failed Prosthetic Graft. J Am Coll Surg 2005; 201:223-230.

1

vs. ePTFE

ProCol has a 60% secondary patency rate at 2 years(vs. 18% with ePTFE)1

NR = not reported; ^Data from intent to treat Kaplan-Meier analyses

vs. ePTFE

ProCol has a76% secondary patency rate at 2 years (vs. 35% with ePTFE)1

1. Glickman MH, Lawson JH, Katzman HE, et al. Multicenter Results of Using a Mesenteric Vein Bioprosthesis (ProCol®) as a Conduit for Hemoaccess in Patients with Multiple ePTFE Grafts Placed in the Leg. 29th Global Vascular and Endovascular Issues, Techniques and Horizons. 2002.

NR = not reported; ^Data from intent to treat Kaplan-Meier analyses

Compared with synthetic grafts, ProCol has:

• 3.7 times lower relative risk to infection1

• 1.4 times lower relative risk to intervention1

ProCol ePTFE0

0.05

0.1

0.15

0.2

0.25

0.05

0.2

Infection (event rate per

year)1

ProCol ePTFE0

0.5

1

1.50.97

1.37

Interventions (event rate

per year)1

1. Katzman HE, Glickman MH, Schild AF, et al. Multicenter Evaluation of the Bovine Mesenteric Vein Bioprosthesis for Hemodialysis Access in Patients with an Earlier Failed Prosthetic Graft. J Am Coll Surg 2005; 201:223-230.

vs. ePTFE

ProCol ePTFE0

0.010.020.030.040.050.06

0.016

0.055

Pseudoaneurysms (event rate per

year)1

Compared with ePTFE, ProCol has shown a3.4 lower pseudoaneurysm event rate per year1

1. ProCol Vascular Bioprosthesis. Instructions for Use. Hancock Jaffe Laboratories, Inc.

vs. ePTFE

vs. AVF

Gensler TW, Stout CL, Glickman MH. Grafts are Superior to Basilic Vein Transposition Arteriovenous Fistulae. Presented at VEITH SYMPOSIUM Nov 2008; New York, NY.

Other Benefits

• Strength and durability1 • Anastomotic compliance • Minimal needle hole bleeding• Biocompatible

1. Glickman, et al. Multicenter Results of Using a Mesenteric Vein Bioprosthesis (ProCol®) as a Conduit for Hemoaccess in Patients with Multiple ePTFE Grafts Placed in the Leg. 29th Global Vascular and Endovascular Issues, Techniques and Horizons. 2002

Product Information1

• Prep Time: approximately 5 minutes• Shelf Life: 54 months• Storage: ambient temperature• Cannulation: allow at least 2 weeks before use

for vascular access (see Instructions for Use for full details)

1. ProCol Vascular Bioprosthesis. Instructions for Use. Hancock Jaffe Laboratories, Inc.

INDICATIONS FOR USE: The ProCol Vascular Bioprosthesis is intended for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft. CONTRAINDICATIONS: None known. WARNINGS: The device should not be used when host vessels are of insufficient quality to avoid anastomotic aneurysms. The device should not be used unless

there is adequate runoff. The safety and effectiveness of the ProCol Vascular Bioprosthesis in de novo patients have not been established. POTENTIAL ADVERSE EVENTS: The following adverse events may be associated with the use of a vascular access graft: needle stick damage resulting in bleeding and/or pseudoaneurysms, hemorrhage, anastomotic aneurysms, steal, patient

sensitivity to device materials, graft dilatation, thrombosis/occlusion of graft, infection, swelling of affected limb, embolic events, stenosis, slow wound healing, failure to achieve access, events associated with an invasive surgical procedure.

INDICATIONS FOR USE: The ProCol Vascular Bioprosthesis is intended for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft. CONTRAINDICATIONS: None known. WARNINGS: The device should not be used when host vessels are of insufficient quality to avoid anastomotic aneurysms. The device should not be used unless there is adequate runoff. The safety and effectiveness of the ProCol Vascular Bioprosthesis in de novo patients have not been established. POTENTIAL ADVERSE EVENTS: The following adverse events may be associated with the use of a vascular access graft: needle stick damage resulting in bleeding and/or pseudoaneurysms, hemorrhage, anastomotic aneurysms, steal, patient sensitivity to device materials, graft dilatation, thrombosis/occlusion of graft, infection, swelling of affected limb, embolic events, stenosis, slow wound healing, failure to achieve access, events associated with an invasive surgical procedure.

Rx only

Product Information (continued)1

1. ProCol Vascular Bioprosthesis. Instructions for Use. Hancock Jaffe Laboratories, Inc.

ProCol is manufactured by Hancock Jaffe Laboratories, Inc.and distributed by CryoLife, Inc.