Professional Documents
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Selection bias
1,4
Underpowered % of participants were not eligible/did 2,3,4 not receive treatment/crossed over
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.
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
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.
21.3% 21.0%
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.
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.
V12
V12
Embolic debris trapped against vessel wall during V12 dog-bone ination
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.
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.
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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.
Clinical Experiences
Renal Stenosis > Optimal treatment strategy for renal artery stenosis. PTFE stent encapsulation minimizes neointimal in-growth and renal restenosis.
Renal Fenestration > Covered renal stents are associated with a lower incidence of in-stent stenosis and are thus recommended over bare metal stents...1
*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.
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
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
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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.