v12 case report booklet 0519

CaseStudy

Report

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Vascular V12Covered Stent

The New Standard of Care

Total Occlusive DiseasePatient History:Female with left leg claudication, Rutherford Classification 4

Angiography:Total occlusion of left common iliac artery just below aortic bifurcation

Procedural Course:• Left femoral access was gained and lesion was crossed with an .035" guidewire.

• 7Fr sheath was advanced over the wire through the CTO to healthy segment of common iliac artery.

• 7mm x 38mm V12 was successfully deployed .

Conclusion:This case had an excellent clinical outcome with patency restored to the left common iliac artery.

Left Common Iliac Artery Total Occlusion 7mm x 38mm Atrium V12 Stent Deployed inLeft Common Iliac Artery with Patency Restored


V12 OTW 5-12mm

In-Stent RestenosisPatient History:A 61 year old male smoker with a history of peripheral vascular disease underwent endovascular treatment fordiffuse bilateral aortoiliac disease one year prior. A bare metal stent was placed in the right common iliac arteryand a covered self expanding stent was placed in the left common Iliac artery. The patient presented withsymptoms of reocclusion.

Angiography:3-D pelvic arteriogram demonstrated a 2cm long, moderate stenosis at the origin of the right common iliac artery.There was a chronic total occlusion of the left common and external iliac arteries with reconstitution at theacetabulum of the common femoral artery.

Procedural Course:• Bilateral 7Fr femoral sheaths were inserted and .035” wires were advanced into the abdominal aorta.

• PTA was performed using a 7mm x 60mm balloon across the entire length of the occluded segment.

• 10mm x 38mm Atrium V12 stent was advanced through the right sheath to the aortic bifurcationand a 9mm x 59mm V12 stent was advanced up the left sheath to the aortic bifurcation.

• V12 stents were deployed in a “kissing” fashion to “re-build” the aortic bifurcation.

• Left iliac stent was extended using a 7mm x 59mm V12 stent and further extended with a 9mm x 60mm self expanding stent.

• Post stent angioplasty was performed on the right with a 10mm x 40mm balloon and a 9mm x40mm balloon on the left along the entire stented segment.

Conclusion:This case demonstrated the ability of the V12 stent to successfully remodel the aortic bifurcation.

Distal Aortic Disease with RightCommon Iliac Stenosis & LeftCommon Iliac Total Occlusion

10mm x 38mm V12 Deployed in RightCommon Iliac & 9mm x 59mm

V12 Deployed in Left Common Iliac

Aortoiliac Bifurcation SuccessfullyRemodeled with V12 Kissing Stents

V12 OTW 5-12mm

Aorto-Iliac Occlusive DiseaseAngiography:Total occlusion of the aorta and bilateral iliac arteries

Procedural Course:• 9Fr and 7Fr femoral sheaths were placed.

• 12mm x 61mm and 12mm x 29mm LD V12 stents were overlapped in the distal aorta and post dilated to16mm with a 16mm x 40mm PTA balloon.

• Bilateral common iliac arteries were remodeled with two 8mm x 59mm V12 stents.

Conclusion:Excellent clinical result with restoration of blood flow to distal aorta & common iliac arteries

V12 LD 12-22mmV12 OTW 5-12mm

Total Occlusion of the Aorta &Bilateral Common Iliac Arteries

12mm x 29mm & 12mm x 61mm LD V12 StentsOverlapped in Distal Aorta & Post Dilated to 16mm.Bilateral Common Iliac Arteries Remodeled withTwo 8mm x 59mm V12 Stents. Physician chose to

Exclude Lumbar Arteries.


*V12 is CE approved for restoring the patency of iliac and renal arteries

V12 OTW 5-12mm

Bilateral StenosisPatient History:69 year old female with a history of Type II Diabetes and medically resistant hypertension

Angiography:Severe bilateral renal artery stenosis

Procedural Course:• Bilateral femoral access was obtained. 6Fr introducer sheath was advanced to left renal ostium.

• The lesion was pre-dilated with a 3mm x 15mm PTA balloon.

• 6mm x16mm V12 OTW was deployed in the left renal artery.

• 6Fr introducer sheath was advanced to the right renal ostium.

• 6mm x 22mm V12 was deployed in the right renal artery with the proximal 2-3mm extending into theaorta and flared with a 7mm x 10mm PTA balloon.

Conclusion:This case demonstrated the one step deployment of the V12 balloon expandable covered stent. Thephysician was able to precisely place bilateral V12 stents across the lesions and restore patency to the renalarteries.

Severe Bilateral Renal Stenosis 6mm x 16mm V12 Deployed in Left Renal Artery.6mm x 22mm V12 Deployed in Right Renal Artery.

Patency Restored to Bilateral Renal Arteries.

In-Stent StenosisPatient History:63 year old patient with a history of renal artery disease with worsening renal function.Bilateral bare metal stents were previously placed in the renal arteries.

Angiography:95% right renal artery restenosis

Procedural Course:• Right renal artery was accessed by telescoping an 8Fr introducer sheath over an 8Fr LIMA guide catheter.

• 3mm coronary PTA balloon was used to pre-dilate the vessel, allowing the guide catheter to cross the lesion.

• 6mm x 22mm V12 was deployed across the renal artery lesion, with 2mm extending into the aorta at the ostium.

• Proximal end of stent was flared with a 7mm x 15mm balloon to improve wall apposition at the ostium.

Conclusion:Excellent clinical outcome was achieved with patency restored to the right renal artery.

Right Renal Artery Bare Metal In-Stent Restenosis 6mm x 22mm V12 Placed within the Existing BareMetal Stent with Right Renal Artery Patency Restored


V12 OTW 5-12mmV12 RX 5-8mm

In-Stent StenosisPatient History:76 year old female with refractory hypertension, previously treated with a left renal artery bare metal stent

Angiography:Significant bare metal in-stent restenosis within the right renal artery

Procedural Course:• 6Fr catheter was used to access the renal artery with an .014” guidewire.

• Pre-dilation was performed with a 3mm x 20mm PTA balloon.

• 5mm x 21mm V12 RX was delivered through the catheter and deployed within the bare metal stent.

Conclusion:This case demonstrated the superior deliverability of the new V12 RX with patency restoredto the left renal artery.

Left Renal Artery Bare Metal Stent Stenosis 5mm x 21mm V12 RX Deployed inLeft Renal Artery with Patency Restored

V12 RX 5-8mm


RenalPatient History:68 year old smoker diagnosed with an abdominal aortic aneurysm after a pre-screening exam

Angiography:Type III thoracoabdominal aneurysm

Procedural Course:• Customized Endo AAA device was placed with alignment of the fenestrations with the visceral vessels.

• Bilateral renal ostiums were engaged with guiding catheters through the fenestrations using extra stiff guidewires.

• Bilateral 7mm x 22mm V12 stents were deployed in renal arteries, securing the main body aortic side wall atthe visceral ostium.

• Distal segments of composite device were placed and deployed.

• CT showed exclusion of AAA with patent visceral vessels.

Conclusion:Utilizing a V12 balloon expandable covered stent in conjunction with a fenestrated AAA device led to an excellentclinical result. The V12 has superior radial strength and offers the ability to be customized, thus creating a tight sealto effectively exclude an aneurysm.

Successful Deployment of 7mm x 22mm V12 Stents in RenalArteries through the Renal Fenestrations of a AAA Device

V12 RX 5-8mmV12 OTW 5-12mm

CoarctationPatient History:20 year old female with aortic coarctation

Angiography:Pre-stenting Assessment:

• Pressure gradient = 18mmHg (gradient was low due to collateral flow)

Aortic measurements:• Transverse arch = 13mm, descending aorta = 12mm, coarctation < 2mm

Procedural Course:• Case initially started with a Glidewire® with difficulty passing pigtail through the coarctation.

Wire was exchanged for 0.035” Amplatz guide wire.

• The difficult passing of a 5Fr pigtail catheter through the coarctation indicated the narrowingwas less than 2mm in diameter, therefore pre-dilation was required.

• 5mm x 20mm PTA balloon was used to pre-dilate the coarctation.

• 11Fr x 75cm sheath was advanced across the coarctation.

• LD V12 14mm x 41mm was advanced through sheath and positioned appropriately.

• Sheath was retracted and stent was deployed.

• LD V12 balloon was re-inflated within the stent to ensure adequate stent wall apposition.

• LD V12 balloon was deflated and removed from the patient.

• An excellent clinical result was obtained, with a post stenting pressure gradient equalling 0mmHg.

Conclusion:This case demonstrated a life altering application in which V12 was utilized.

Severe Coarctation < 2mm inDiameter

Pre-dilation with a5mm x 20mm Balloon

LD V12 12mm x 41mmPositioned

LD V12 Post Deployment,with Excellent Clinical Result

*V12 is currently under investigation for the treatment of aortic coarctationV12 LD 12-22mm

CoarctationPatient History:16 year old female with coarctation of the aorta who had previous balloon dilation during infancy

Angiography:Coarctation of the aorta measuring 7-8mm

Procedural Course:• LD V12 12mm x 41mm was deployed.

• LD V12 was post dilated to 16mm with a LD balloon.

Conclusion:Excellent clinical result

This case showed theability of the LD V12 tobe post dilated.

The LD V12 can safelybe post dilated to22mm.


Coarctation Clinical ReviewProspective study to examine the acute results of treating a Coarctation of the Aorta with theAdvanta™ V12 Large Diameter Stent

Atriumcovered stent

ProceduralSuccess

Number ofPatients

CoarctationDiameter Size

Peak PressureGradient

Pre-Stent100% 25

6.3mm 25.3mmHg

Post-Stent 14.4mm* 2.5mmHg*

CT Image of Aortic Coarctation Final Result After LD V12 12mm x 41mmDeployed and Post Dilated to 16mm

Coarctation of the Aorta Treated with the Advanta V12 Large Diameter stent: Acute Results. Bruckheimer et al. Catheterization and Cardiovascular Interventions, 2010, Volume 75

*Indicates statistical significanceV12 LD 12-22mm *V12 is currently under investigation for the treatment of aortic coarctation

Iliac Clinical Review

Renal Clinical Review

COBEST Trial: A comparison of Atrium’s vascular V12 balloon expandable covered stent vs bare metal stents for the treatment of aortoiliac occlusive disease.Patrice Mwipatayi, MD et al, JVS 2011

TVR (18 months)B, C, & D Lesions

Freedom from Restenosis(18 months) C & D Lesions

Freedom from Occlusion(18 months)

V12 3%* 88%* 93%BMS 16% 46% 82%

Kissing Stent TrialReview of Covered vs. Bare Metal Kissing Stents used to treat Aortoiliac Lesions

Outcomes of Covered Kissing Stent Placement Compared with Bare Metal Stent Placement in the Treatment of Atherosclerotic Occlusive Disease at the AorticBifurcation. Sabri et al, JVIR, July 2010, Volume 21, Number 7

Sustained ClinicalImprovement (2 yrs) Primary Patency (1 yr) Primary Patency (2 yrs)

Atrium Covered Stent 84% 92%* 92%*BMS 54% 78% 62%

Prospective, Randomized, Controlled, Multi-Center (12 sites) clinical trialcomparing V12 Covered Stent to Bare Metal Stents for use in Iliac occlusive disease

Renal Fenestration StudyProspective study that compared outcomes of Covered vs. Bare Metal stents when used along withfenestrated AAA devices during endovascular repair of abdominal aneurysms

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

Number ofPatients

Renal Occlusion Rate(2 yrs)

Overall Renal Restenosis/OcclusionRate (2 yrs)

Bx Covered Stents 129 2.2%* 5%*BMS 158 4.5% 17%

Renal Restenosis StudyReview of Atrium balloon expandable PTFE covered stent placement for the treatment of renal arteryin-stent restenosis

The Utilization of PTFE Covered Stents for the Treatment of Renal Artery In-Stent Restenosis. Ansel et al. JACC, March 2010, Volume 55, Issue 10A

Procedural Success Number of Renal Arteries Treated In-Stent Restenosis (~1 yr)

Atrium covered stent 100% 30 0%

*Indicates statistical significance

Proven ClinicalPerformance

© Atrium Medical Corporation 2011. All rights reserved. Printed in U.S.A. 12/11 Part #0519. Atrium and Advanta are trademarks of Atrium Medical Corporation.V12 is not available in the U.S. V12 is CE approved for use in iliac and renal arteries.

www.atriummed.com

ATRIUM MEDICAL CORPORATION ATRIUM EUROPE B.V. ATRIUM AUSTRALIA-PACIFIC RIM PTY. LTD.5 Wentworth Drive Rendementsweg 20 B Level 6, 579 Harris StreetHudson, New Hampshire 03051 U.S.A. 3641 SL Mijdrecht, The Netherlands Ultimo NSW 2007 Australia 603-880-1433 603-880-6718 +31 297 230 420 +31 297 282 653 +61 2 8272 3100 +61 2 8272 3199

Advanta™ V12 is CE approved for restoring the patency of iliac and renal arteries.Renal approval is for 5-7mm sizes. Advanta™ V12 is not available in the U.S.

StentDiameter/Length

V12 OTWOrderingInformation Introducer/

GuideCatheter

Compatibility+Code #80 cmCatheterLength

Code #120 cmCatheterLength

5 x 16 mm 85340 85350 6 FR/8 FR

5 x 22 mm 85341 85351 6 FR/8 FR

5 x 38 mm 85320 85330 7 FR/9 FR

5 x 59 mm 85321 85331 7 FR/9 FR

6 x 16 mm 85342 85352 6 FR/8 FR

6 x 22 mm 85343 85353 6 FR/8 FR

6 x 38 mm 85322 85332 7 FR/9 FR

6 x 59 mm 85323 85333 7 FR/9 FR

7 x 16 mm 85344 85354 7 FR/9 FR

7 x 22 mm 85345 85355 7 FR/9 FR

7 x 38 mm 85324 85334 7 FR/9 FR

7 x 59 mm 85325 85335 7 FR/9 FR

8 x 38 mm 85326 85336 7 FR/9 FR

8 x 59 mm 85327 85337 7 FR/9 FR

9 x 38 mm 85328 85338 7 FR/9 FR

9 x 59 mm 85329 85339 7 FR/9 FR

10 x 38 mm 85360 85364 7 FR/9 FR

10 x 59 mm 85361 85365 7 FR/9 FR


V12 OTWOrderingInformation

IntroducerCompatibilityCode #

80 cmCatheterLength

Code #120 cmCatheterLength

12 x 29 mm 85370 85379 9 FR

12 x 41 mm 85371 85380 9 FR

12 x 61 mm 85372 85381 9 FR

14 x 29 mm 85373 85382 11 FR

14 x 41 mm 85374 85383 11 FR

14 x 61 mm 85375 85384 11 FR

16 x 29 mm 85376 85385 11 FR

16 x 41 mm 85377 85386 11 FR

16 x 61 mm 85378 85387 11 FR


V12 RX OrderingInformation Introducer/

GuideCatheter

Compatibility+Code #

80 cmCatheterLength

Code #

140 cmCatheterLength

5 x 16 mm 85229 85278 5 FR/6 FR

5 x 21 mm 85230 85279 5 FR/6 FR

5 x 24 mm 85231 85280 5 FR/6 FR

6 x 16 mm 85236 85285 5 FR/6 FR

6 x 21 mm 85237 85286 5 FR/6 FR

6 x 24 mm 85238 85287 5 FR/6 FR

7 x 16 mm 85243 85292 6 FR/7 FR

7 x 21 mm 85244 85293 6 FR/7 FR

7 x 24 mm 85245 85294 6 FR/7 FR

>Able to be post-dilatedup to 8mm

>Able to be post-dilatedup to 22mm

>Able to be post-dilatedup to 12mm*

+ Most Common Size Guide Catheters were tested

+ Most Common Size Guide Catheters were tested*38mm and 59mm sizes

•014"GUIDEWIRE

•035"GUIDEWIRE

•035"GUIDEWIRE


v12 case report booklet 0519

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