Vascular V12

Covered Stent

Case Study Report

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Vascular V12
Covered Stent

Total Occlusive Disease

Patient 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 in Left Common Iliac Artery with Patency Restored

V12 OTW 5-12mm

In-Stent Restenosis
Patient History: A 61 year old male smoker with a history of peripheral vascular disease underwent endovascular treatment for diuse bilateral aortoiliac disease one year prior. A bare metal stent was placed in the right common iliac artery and a covered self expanding stent was placed in the left common Iliac artery. The patient presented with symptoms 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 the acetabulum 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 bifurcation and 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 x 40mm 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 Right Common Iliac Stenosis & Left Common Iliac Total Occlusion

10mm x 38mm V12 Deployed in Right Common Iliac & 9mm x 59mm V12 Deployed in Left Common Iliac

Aortoiliac Bifurcation Successfully Remodeled with V12 Kissing Stents

V12 OTW 5-12mm

Vascular V12
Covered Stent

Aorto-Iliac Occlusive Disease

Angiography: 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 to 16mm 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

Total Occlusion of the Aorta & Bilateral Common Iliac Arteries

12mm x 29mm & 12mm x 61mm LD V12 Stents Overlapped in Distal Aorta & Post Dilated to 16mm. Bilateral Common Iliac Arteries Remodeled with Two 8mm x 59mm V12 Stents. Physician chose to Exclude Lumbar Arteries.

V12 LD 12-22mm V12 OTW 5-12mm

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

Bilateral Stenosis
Patient 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 the aorta and flared with a 7mm x 10mm PTA balloon. Conclusion: This case demonstrated the one step deployment of the V12 balloon expandable covered stent. The physician was able to precisely place bilateral V12 stents across the lesions and restore patency to the renal arteries.

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.

V12 OTW 5-12mm

Vascular V12
Covered Stent

In-Stent Stenosis
Patient 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 Bare Metal Stent with Right Renal Artery Patency Restored

V12 OTW 5-12mm V12 RX 5-8mm

In-Stent Stenosis
Patient 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 restored to the left renal artery.

Left Renal Artery Bare Metal Stent Stenosis

5mm x 21mm V12 RX Deployed in Left Renal Artery with Patency Restored

V12 RX 5-8mm

Vascular V12
Covered Stent

Renal
Patient 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 sti guide wires. Bilateral 7mm x 22mm V12 stents were deployed in renal arteries, securing the main body aortic side wall at the 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 excellent clinical result. The V12 has superior radial strength and oers the ability to be customized, thus creating a tight seal to eectively exclude an aneurysm.

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

V12 RX 5-8mm V12 OTW 5-12mm

Coarctation
Patient 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 diculty passing pigtail through the coarctation. Wire was exchanged for 0.035 Amplatz guide wire. The dicult passing of a 5Fr pigtail catheter through the coarctation indicated the narrowing was 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 in Diameter

Pre-dilation with a 5mm x 20mm Balloon

LD V12 12mm x 41mm Positioned

LD V12 Post Deployment, with Excellent Clinical Result

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

Vascular V12
Covered Stent

Coarctation
Patient 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 the ability of the LD V12 to be post dilated. The LD V12 can safely be post dilated to 22mm.

CT Image of Aortic Coarctation

Final Result After LD V12 12mm x 41mm Deployed and Post Dilated to 16mm

Coarctation Clinical Review

Prospective study to examine the acute results of treating a Coarctation of the Aorta with the Advanta V12 Large Diameter Stent
Atrium covered stent Pre-Stent Post-Stent Procedural Success Number of Patients Coarctation Diameter Size 6.3mm Peak Pressure Gradient 25.3mmHg

100%

25

14.4mm*

2.5mmHg*

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

V12 LD 12-22mm

*V12 is currently under investigation for the treatment of aortic coarctation *Indicates statistical significance

Iliac Clinical Review

Prospective, Randomized, Controlled, Multi-Center (12 sites) clinical trial comparing V12 Covered Stent to Bare Metal Stents for use in Iliac occlusive disease
TVR (18 months) B, C, & D Lesions V12 Freedom from Restenosis (18 months) C & D Lesions Freedom from Occlusion (18 months)

3%*
16%

88%*
46%

93%
82%

BMS

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

Kissing Stent Trial Review of Covered vs. Bare Metal Kissing Stents used to treat Aortoiliac Lesions
Sustained Clinical Improvement (2 yrs) Primary Patency (1 yr) Primary Patency (2 yrs)

Atrium Covered Stent

BMS

84%
54%

92%*
78%

92%*
62%

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

Renal Clinical Review

Renal Fenestration Study Prospective study that compared outcomes of Covered vs. Bare Metal stents when used along with fenestrated AAA devices during endovascular repair of abdominal aneurysms
Number of Patients Renal Occlusion Rate (2 yrs) Overall Renal Restenosis/Occlusion Rate (2 yrs)

Bx Covered Stents
BMS

129
158

2.2%*
4.5%

5%*
17%

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

Renal Restenosis Study Review of Atrium balloon expandable PTFE covered stent placement for the treatment of renal artery in-stent restenosis
Procedural Success Number of Renal Arteries Treated In-Stent Restenosis (~1 yr)

Atrium covered stent

100%

30

0%

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

*Indicates statistical significance

Proven Clinical Performance

Vascular V12
Covered Stent
014"
Stent Diameter/ Length

>Able to be post-dilated up to 8mm

V12 RX Ordering Information Stent Diameter/ Length
Code # Code #

GUIDEWIRE

>Able to be post-dilated up to 12mm*

V12 OTW Ordering Information
Code # Code #

GUIDEWIRE

035"

80 cm
Catheter Length

140 cm
Catheter Length 85278 85279 85280 85285 85286 85287 85292 85293 85294

Introducer/ Guide Catheter Compatibility+

80 cm
Catheter Length

120 cm
Catheter Length

Introducer/ Guide Catheter Compatibility+

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

85229 85230 85231 85236 85237 85238 85243 85244 85245

5 FR/6 FR 5 FR/6 FR 5 FR/6 FR 5 FR/6 FR 5 FR/6 FR 5 FR/6 FR 6 FR/7 FR 6 FR/7 FR 6 FR/7 FR

5 x 16 mm 5 x 22 mm 5 x 38 mm 5 x 59 mm 6 x 16 mm 6 x 22 mm 6 x 38 mm 6 x 59 mm 7 x 16 mm 7 x 22 mm 7 x 38 mm

85340 85341 85320 85321 85342 85343 85322 85323 85344 85345 85324 85325 85326 85327 85328 85329 85360 85361

85350 85351 85330 85331 85352 85353 85332 85333 85354 85355 85334 85335 85336 85337 85338 85339 85364 85365

6 FR/8 FR 6 FR/8 FR 7 FR/9 FR 7 FR/9 FR 6 FR/8 FR 6 FR/8 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR 7 FR/9 FR

+ Most Common Size Guide Catheters were tested

>Able to be post-dilated up to 22mm

V12 OTW Ordering Information
Code # Code #

GUIDEWIRE

035"

7 x 59 mm 8 x 38 mm 8 x 59 mm 9 x 38 mm

Stent Diameter/ Length

80 cm
Catheter Length

120 cm
Catheter Length

Introducer Compatibility

9 x 59 mm 10 x 38 mm 10 x 59 mm

12 x 29 mm 12 x 41 mm 12 x 61 mm 14 x 29 mm 14 x 41 mm 14 x 61 mm 16 x 29 mm 16 x 41 mm 16 x 61 mm

85370 85371 85372 85373 85374 85375 85376 85377 85378

85379 85380 85381 85382 85383 85384 85385 85386 85387

9 FR 9 FR 9 FR 11 FR 11 FR 11 FR 11 FR 11 FR 11 FR

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

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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.