CryoVein® CryoArtery®

AV Access

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Overview

• Ideal Patients

• Clinical Outcomes

• Additional Benefits

• The CryoLife Difference

• Implanting Technique

• Available Allografts & Sizes

• Discussion

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Ideal Patients*

Patients with active infections due to either:

• Infected AV fistula

• Infected synthetic AV graft

Patients in whom an autologous AV fistula is not possible

Patients at risk of an AV access infection

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Patients with a limited number of AV access sites

NOTE: Transplantation of any allograft tissue can induce an anti-HLA antibody response in the recipient. The possibility that a patient may develop antibodies after allograft tissue transplantation should be considered for any patient who might be a future recipient of allograft tissue, organs, or cells.

*Based on current technology/understanding

Up to 35% of AV grafts become infected1

Estimated AV Access Graft Infection in U.S. is 13,0002

1Akoh J. J Vasc Access 2009;10:137-47. 2Calculated estimate based on forecasted procedures from iData Research Inc. Surgical Graft Procedure Numbers by Segment, U.S., 2006-2016.

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Ideal Patients: AV Access Infections

Allografts For Treating AV Graft Infections

CryoVein Femoral Vein

Patients Treated for AV Graft Infection

Re-infection Rates

Rate of Infection per

1,000 patient days

Follow Up

Lin et al.1 36 0% NR 1 Year

Matsuura et al.2 38 0% NR 1 Year

Matsuura et al.3 43 2.3% NR 2 Years

CryoLife Multicenter4 52 3% 0.099* 2 Years

1Lin P, et al. Am J Surg 2002;184:31-6. 2Matsuura J, et al. Ann Vasc Surg 2000;12:50-5. 3Matsuura J, et al. Cardiovasc Surg 2002. 10;6:561-65. 4CryoLife data on file (ML0101).

Clinical Outcomes: CryoVein Femoral Vein

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*This calculation is based on the subset of patients treated for an AVG infection, n=52 (20,017 cumulative patient days). The full series, n=148, rate of infection is 0.0062 per 1,000 patient days (48,223 cumulative patient days).

Clinical Outcomes: CryoVein Femoral Vein

CryoVein Femoral Vein Patients 1 Year

Cumulative Patency

2 Year Cumulative

Patency

Lin et al.1 38 68% -

Matsuura et al.2 44 75% -

Matsuura et al.3 43 68% 63%

CryoLife Multicenter4 148 80% 72%

1Lin P, et al. Am J Surg 2002;184:31-6. 2Matsuura J, et al. Ann Vasc Surg 2000;12:50-5. 3Matsuura J, et al. Cardiovasc Surg 2002. 10;6:561-65. 4CryoLife data on file (ML0101).

Allografts For AV Access: Cumulative Patency

Femoral Vein

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Clinical Outcomes: Cryopreserved Femoral Artery

Cryopreserved Femoral Artery*

Patients

1 Year Cumulative

Patency

2 Year Cumulative

Patency

Takamoto et al.1 5 100% 80%

1Takamoto S, et al. Trans Proceed 1998;30:3917-19.

Allografts For AV Access: Cumulative Patency

Femoral Artery

*non-CryoLife processed tissue

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Clinical Outcomes: Cryopreserved Saphenous Vein

Cryopreserved Saphenous Vein*

Patients 1 Year Cumulative

Patency

Baraldi et al.1 16 90%

1Baraldi A, et al. Trans Am Soc Artif Intern Organs 1989:196-9.

Allografts For AV Access: Cumulative Patency

Saphenous Vein

*non-CryoLife processed tissue

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Additional Benefits: Save the Site vs. Lose the Site

Allograft Method Single procedure: save the site1,2

Graft Excision Method Multiple procedures: lose the site1,2

1) Remove infected AV graft and implant allograft in the same infected site, saving potential future AV access sites

2) Insert a temporary dialysis catheter and begin IV antibiotic therapy

1) Remove infected AV graft

2) Insert a temporary dialysis catheter and begin IV antibiotic therapy

3) After the infection is cleared, perform another operation with a new AV graft in a different location, diminishing potential sites for future AV access

1Lin P, et al. Am J Surg 2002;184:31-6. 2Matsuura J. Contemp Dial & Neph 1999:30-2.

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Surgical technique is at the discretion of the surgeon. Variations in technique and practices will inevitably and appropriately occur when clinicians take into account the needs of the individual patients, available resources, and limitations unique to an institution or type of practice.

Additional Benefits: Cost Effectiveness

Treatment Methods Patients

Average hospital stay

(p=0.001)

Overall hospital cost

CryoVein Femoral Vein 20 2.3 days $13,843 ±

$6,007

Graft Excision 13 8.1 days $22,136 ± $12,665

Cost Comparison: CryoVein Femoral Vein vs. Graft Excision1

Conclusion: Cryopreserved femoral vein is a cost-effective means of treating infected AV grafts1

1Matsuura J, et al. Presented at the 10th Annual Winter Meeting of the Peripheral Vascular Surgery Society, Snowmass, CO. January 14, 2000.

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Additional Benefits: Natural Suturability

Looks, feels, and sutures like autologous tissue1

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1Martin et al. Ann Surg 1994 Jun;219(6):664-70.

Additional Benefits: Natural Pulsatile Flow

Flow dynamics of cryopreserved vascular allografts are comparable to that of autologous tissue1

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1Bia D et al. Artif Organs. 2007 Nov;31(11):809-18.

Benefit CryoLife

Safety & Clinical Validation

AATB Accreditation Yes

Clinical Data for AV Access 11 publications

Processing Standards Four stage microbiological testing

Quality

Donor Age Up to 55 years

Detailed Certificate of Assurance (e.g. diameter changes, ligations, leaks, etc.)

Yes

Packaging: Can it be submerged in Liquid Nitrogen?

Yes

The CryoLife Difference 13

Benefit CryoLife

Experience

Year Founded 1984

Service

Representatives Direct

Tissues Femoral Vein & Artery; Saphenous Vein

CryoFreezers for Hospitals Yes

Professional Education (wet labs) Yes

The CryoLife Difference 14

Implanting Technique

Remove infected AV graft and implant allograft in the same infected site, saving potential future AV access sites

Insert a temporary dialysis catheter and begin IV antibiotic therapy

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Implanting Technique 16

Alternative techniques:

CryoVein/CryoArtery as interpositional graft: ◦ Remove infected area of AVF or AVG

◦ Replace with CryoVein/CryoArtery in the same infected site

CryoVein/CryoArtery as jump graft for fistula salvage

Implanting Technique

To optimize flow, taper the arterial end of the CryoVein Femoral Vein using an angled cut of the allograft and oversewing the heel of the graft with 6-0 polypropylene suture to create a 4mm1, 5mm2, or 6mm diameter.3

For informational purposes only. Surgical technique is at the discretion of the surgeon.

1Lin P, et al. Am J Surg 2002;184:31-6. 2Matsuura J, et al. Ann Vasc Surg 2000;12:50-5. 3Matsuura J, et al. Cardiovasc Surg 2002. 10;6:561-65. Images from: Matsuura J, et al. Perspectives in Vascular Surgery 2000. 13(1):71-80.

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Access is possible 10 to 14 days after implantation1,2

The use of clamps post-dialysis should be restricted3

Rotating cannulation sites is recommended4

Buttonhole has been reported5

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Implanting Technique

1Matsuura J, et al. Ann Vasc Surg 2000;12:50-5. 2Matsuura J, et al. Cardiovasc Surg 2002. 10;6:561-65. 3www.fistulafirst.org. Clamp Usage Policy and Procedure. 4KDOQI Guidelines for AV Graft Cannulation, Guideline 3.3. 5Gallichio et al. Presented at VASA Meeting, May 2012.

Available Allografts & Sizes

Femoral Vein

Femoral Artery

Saphenous Vein

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Tissue Type Diameter Length Catalog #

Femoral Vein 6 mm – 15 mm 10 cm – 30+ cm V060

Saphenous Vein* 3 mm – 6 mm 20 cm – 80+ cm V010

CryoVein

Tissue Type Diameter Length Catalog #

Femoral Artery 4 mm – 5+ mm 10 cm – 30+ cm R020

CryoArtery

*Pressurized

Discussion 20 All trademarks are registered trademarks of CryoLife, Inc. © 2013 CryoLife, Inc. All rights reserved.

Image shown above is not intended to depict all possible access site locations.

Which sites do you typically choose?

Why?

How can CryoVein and CryoArtery fit into your treatment algorithm?

ML0671.000