Renal Clinical Data

Limitations of Prior Renal Randomized Controlled Trials

Prior renal focused trials such as the ASTRAL, STAR and DRASTIC, failed to show a clear benefit of renal artery stenting compared to medical therapy alone. Numerous critiques on the methodology and design of these trials have been published. The limitations of these studies and how they have impacted the outcomes of the trials are briefly outlined below.

Limitations of Prior Renal Trials

Implications on Trial Outcomes

Physicians had to be undecided on whether the patient should undergo revascularization or medical management alone which led to excluding patients who would have benefited from revascularization.4 Asymptomatic or minimally symptomatic patients were enrolled and unlikely to benefit from revascularization.1

Selection bias

1,4

Underpowered % of participants were not eligible/did 2,3,4 not receive treatment/crossed over

Underpowered studies can lack evidence or be misleading.

Low numbers of enrollment per year with high rates of adverse 4 events observed

Not consistent with historically low adverse event rates for renal stenting. This may have contributed to the neutral outcomes. The degree of stenosis was likely overestimated by visual inspection and was not validated.4 Patients were enrolled at physician's discretion.

No core laboratory or Objective enrollment criteria

2,3,4

1. 2. 3. 4.

White J. Kiss My Astral: One Seriously Flawed Study of Renal Artery Stenting After Another. Catheterization and Cardiovascular Interventions 2010; Volume 75: 305-307. Bax L, et al. Stent Placement In Patients with Atherosclerotic Renal Artery Stenosis and Impaired Renal Function: a Randomized Trial. Annals of Internal Medicine 2009; Volume 150, Issue 12: 840-848. Jaarsveld B, Et Al. The Eect of Balloon Angioplasty on Hypertension in Atherosclerotic Renal-Artery Stenosis. New England Journal of Medicine 2000; Volume 342:1007-1014. Wheatley K, et al. J. Revascularization Versus Medical Therapy for Renal-Artery Stenosis. New England Journal of Medicine 2009; 361:19531962.

Unsurpassed Deliverability

Is Renal Artery Stenting the Right Choice for Your Patient?

ASTRAL and STAR demonstrated that careful patient selection is critical for successful endovascular treatment of renal artery disease. The following conditions can help you determine if renal artery stenting is the right choice for your patient.

Patients that Do NOT Benet from Renal Artery Stenting

Patients with renal function that has remained stable over the past 6 to 12 months and hypertension that can be controlled medically9 Patients with preserved or even decreased but stable renal function9 Hemodynamically non-significant stenosis with arterial hypertension or renal function impairment from other etiologies10 Patients with high intrarenal resistive index > 0.81 Patients with a stenosed renal artery supplying a small atrophic kidney1,2

Patients that Do Benet from Renal Artery Stenting

Hemodynamically significant renal artery stenosis (RAS) 70%5 Resistant hypertension despite the use of >3 antihypertensive agents of different classes, including a diuretic9 Unilateral RAS of a single kidney and bilateral RAS1 Patients with bilateral stenosis with flash pulmonary edema1,9 Progressive decline in GFR during treatment of hypertension with ACE inhibitors or ARBs11 Intrarenal resistive index < 0.89 Translesional pressure gradient > 20mm Hg4,8 Normal kidney size of > 8.0cm1 Patients with CKD stages 4/56 (The above criteria may show benet alone or in combination)

1. Adamczak M, Wiecek A. The Management of Atherosclerotic Renovascular Disease. Kidney and Blood Pressure Research 2011; 34 (4):277-83. 2. Chrysochou C, et al. Proteinuria As A Predictor of Renal Functional outcome After Revascularizationin Atherosclerotic Renovascular Disease (ARVD). QJM 2009; 102:283-288. 3. Cheung C, Chrysochou C, Kalra P. The Management of Renovascular Disease: ASTRAL and Beyond. Current Opinion in Nephrology and Hypertension 2011; 20: 89-94. 4. De Bruyne, et al. Assessment of Renal Artery Stenosis Severity by Pressure Gradient Measurements. J Am Coll Cardiology 2006; 48(9):1851-1855. 5. Hirsch, et al.. ACC/AHA Practice Guidelines for The Management of Patients With Peripheral Arterial Disease. Journal of Vascular Interv. Radiology 2006;17:1383-1398. 6. Kalra P, et al.. The Benet of Renal Artery Stenting in Patients With Atheromatous Renovascular Disease and Advanced Chronic Kidney Disease. Catheterization and Cardiovascular Interventions 2010; 75:1-10. 7. Mangiacapra F, et al. Translesional Pressure Gradients to Predict Blood Pressure Response After Renal Artery Stenting in Patients With Renovascular Hypertension. Circ. Cardiovas. Interv. 2010; Dec, 3(6):537-542. 8. Silva J, et al. Elevated Brain Natriuretic Peptide Predicts Blood Pressure Response After Stent Revascularization in Patients with Renal Artery Stenosis. Circulation 2005; 111:328-333. 9. Simon J. Stenting Atherosclerotic Renal Arteries: Time to be Less Aggressive. Cleveland Clinic J Med. 2010, Mar; 77(3):178-189. 10. Sapoval M, et al. One Year Clinical Outcomes of Renal Artery Stenting: The Results of ODORI Registry. Cardiovascular Interventional Radiology 2010, June; 33(3): 475-483. Epub 2009 Nov 12. 11. Textor S, et al. Timing and Selection for Renal Revascularization in an Era Of Negative Trials: What to Do? Progressive Cardiovascular Disease 2009, Nov-Dec;52(3):220-228.

with Ultra Low Profile

Advantages of Atriums Balloon Expandable Covered Stents

Bare Metal Renal Artery Stenting has Demonstrated High Restenosis Rates
Bare Metal Restenosis Rates
1

Study Renaissance Trial Lederman, et al

2

Follow-up Period 9 months 16 months

21.3% 21.0%

Challenges Associated with Bare Metal Stents

Intimal Hyperplasia: Excessive neointimal growth is exhibited with bare metal stents due to vessel wall damage from isolated bare metal stent struts leading to inflammation and smooth muscle disruption.

Rogers and Edelman proved V12 reduced neointimal growth 3 by 80%

Neointimal growth of a bare metal stent at 28 days Neointimal growth of V12 at 28 days

Distal Embolization: Bare metal stents have the ability to disrupt or "cheese grate" plaque and thrombus through the open bare metal struts causing distal embolization. Whereas, V12s simultaneous dog-bone balloon inflation, along with the proprietary PTFE covering, has the ability to trap embolic debris against the vessel wall minimizing embolization.

Bare Metal Stent

V12

V12

Plaque and thrombus dislodged during bare metal stent deployment

Embolic debris trapped against vessel wall during V12 dog-bone ination

V12 deployed with reduced risk of distal embolization

1. Rocha-Singh K, Ja M, Kelley E. Renal Artery Stenting with Noninvasive Duplex Ultrasound Follow-up: 3 Year Results from the RENAISSANCE Renal Stent Trial. Catheterization and Cardiovascular Interventions 2008; 72: 853-862. 2. Lederman R, Mendelsohn F, Santos R, et al. Primary Renal Artery Stenting: Characteristics and Outcomes After 363 Procedures. American Heart Journal 1999; 142(2): 314-323 3. Rogers C, Tseng DY, Gingras PH, Karwoski T, Martakos P, Edelman ER. Expanded Polytetrauoroethylene Stent Graft Encapsulation ReducesIntimal Thickening Regardless of Stent Design. Journal of the American College of Cardiology 1998, Abstract:1163-80.

Confidence Instilled from

Atriums Proven Renal Clinical Data

Treating Renal In-Stent Restenosis with Atriums Covered Stent
Study Ruggiero, II, et al. 2010 Lookstein, 2011 Bray, 2009 3
2 1

Primary Patency 100% 100% 100%

Clinical Follow Up 1 year 13 months 2 years

Ruggiero, II, et al. 20101 - A review of Atriums covered stent for the treatment of renal artery in-stent restenosis. 100% technical success and 100% primary patency at 1 year.

Lookstein, 20112 - Atriums covered stent demonstrated 100% patency in patients that were treated for bare metal in-stent restenosis at 13 months.

Bray, 20093 - Studied the eect of utilizing V12 in renal arteries to treat bare metal in-stent restenosis. Bray reported 100% technical success and 100% patency at 2 years.

Renal Fenestration Study

Number of Stents BX Covered Stent BMS
* statistical signicance p < 0.05

Renal Occlusion Rate (2 yrs) 2.2%* 4.5%

Renal Restenosis Rate (2 yrs) 2.5%* 10%

231 287

Review comparing outcomes of BX covered vs. bare metal stents (BMS) when used in conjunction with fenestrated AAA devices during endovascular repair of abdominal aneurysms4.

1. 2. 3 4.

Ruggiero N, Garasic J, Ja M, et al. The Utilization of PTFE Covered Stents for the Treatment of Renal Artery In-Stent Restenosis. Journal of American College of Cardiology 2010; 55(10A). Lookstein, Robert. The Use of Balloon Expandable Covered Stents for the Treatment of Renal Artery In-Stent Restenosis. VEITH. NYC. 2011. Bray, Alan. Patency of a Covered Stent for Renal Artery In-Stent Restenosis and After Fenestration. Vascular Meeting. Sydney, Australia. 2009. Mohabbat W, Greenberg R, Mastracci T, et al. Revised Duplex Criteria and Outcomes for Renal Stents and Stent Grafts Following Endovascular Repair of Juxtarenal and Thoracoabdominal Aneurysms. Journal of Vascular Surgery 2009; 49: 827-837.

Proven Clinical Outcomes

Clinical Experiences

Renal Stenosis > Optimal treatment strategy for renal artery stenosis. PTFE stent encapsulation minimizes neointimal in-growth and renal restenosis.

Left renal artery stenosis

6 X 24mm V12 RX deployed in renal artery

Renal Aneurysm > Life-saving endovascular solution

Renal artery aneurysm measuring 2.5 cm

5 X 24mm V12 RX stent successfully deployed excluding aneurysm

Renal Fenestration > Covered renal stents are associated with a lower incidence of in-stent stenosis and are thus recommended over bare metal stents...1

Bilateral renal fenestrations with V12 covered stents

Over 150,000 Patients Successfully Treated

1. Revised Duplex Criteria and Outcomes for Renal Stents and Stent Grafts Following Endovascular Repair of Juxtarenal and Thoracoabdominal Aneurysms. Greenberg et al. JVS, April 2009.

V12 RX Covered Stent - Get where you need to go

Product Features
Enhanced deliverability and trackability .014 rapid exchange platform Ultra low profile - 5Fr & 6Fr introducer sheath compatible - 6Fr & 7Fr guide catheter compatible Available in diameters of 5, 6 and 7 mm and lengths of 16, 21 and 24 mm Additional lengths and diameters pending CE approval One-step precision deployment Controls embolic debris

Atriums Superior Covering Technology

Thermo-conformable PTFE covering expands uniformly at body temperature One piece PTFE construction completely encapsulates stent struts Customize to fit vessel anatomy - flare and post-dilate (up to 8mm*) Designed to minimize intimal hyperplasia while still allowing tissue attachment for an optimal fit and healing response

*6 and 7 mm diameters are capable of post-dilation to 8mm V12 RX is CE marked for restoring the patency of iliac and renal arteries V12 RX is TGA registered for restoring the patency of renal arteries. V12 is not available in the U.S.

V12 RX Covered Stent

The World Leader in Balloon Expandable Covered Stents

Over 150,000 patients treated worldwide Over 145 clinical publications and presentations

Ordering Information:
Able to be post-dilated up to 8mm*
Code # 140 cm Catheter Length
85278 85279 85280 85285 85286 85287 85292 85293 85294

.014'' guidewire
Introducer Compatibility Guide Catheter Compatibility+
6 FR 6 FR 6 FR 6 FR 6 FR 6 FR 7 FR 7 FR 7 FR

Stent Diameter/ Length

5 x 16 mm 5 x 21 mm 5 x 24 mm 6 x 16 mm 6 x 21 mm 6 x 24 mm 7 x 16 mm 7 x 21 mm 7 x 24 mm
*6 & 7mm diameters can be post-dilated to 8mm + Most common size guide catheters were tested

5 FR 5 FR 5 FR 5 FR 5 FR 5 FR 6 FR 6 FR 6 FR

To learn more about V12 product offerings, visit us online at: www.atriummed.com

ATRIUM MEDICAL CORPORATION

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ATRIUM AUSTRALIA-PACIFIC RIM PTY. LTD.

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Atrium Medical Corporation 2012. All rights reserved. Printed in U.S.A. 8/12 Part #0562. Atrium and V12 are trademarks of Atrium Medical Corporation, a MAQUET GETINGE GROUP company.

V12 RX is CE marked for restoring the patency of iliac and renal arteries. V12 RX is TGA registered for restoring the patency of renal arteries. V12 is not available in the U.S.