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Advanta V12 balloon expandable covered stent

Right from the start - Still going strong

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Balloon expandable covered stent.
Conformable, deliverable, flexible. Designed to track through tortuous arteries and flex to accommodate the iliac and renal anatomy.
Advanta V12 Balloon Expandable Covered Stent

Advanta V12 balloon expandable covered stent

Advanta V12 is the first to market balloon expandable, fully encapsulated stent that has served more than 850,000 patients. Known for its precision and predictability – the versatile Advanta V12 has been meeting the needs of surgeons and patients for 20 years, and is the only durable solution backed by decades of real-world evidence.[1][2]

Indications:

The Advanta V12 balloon expandable covered stent is indicated for restoring and improving the patency of the iliac and renal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 sizes. In Canada, the Advanta V12 covered stent indication excludes renal arteries.

The Advanta V12 balloon expandable covered stent is not available in the U.S.

 

 

Predictable & Precise

  • Low profile, high stent retention force and secure trackability facilitates the stent implantation [1]

  • Designed for secure delivery & placement: Average stent securement force is 2-4 times higher than peak insertion forces

  • 6 French compatible with most common renal sizes* [1]

  • Radiopaque markers enhance visibility during deployment and assist with accurate stent placement [1]

  • Designed for pushability and trackability through tortuous anatomy with conformance to iliac and renal arteries[1]

  • Predictable recoil and foreshortening provides precise deployment[1]

 
* Please see the Advanta V12 order information found in the documents tab for detailed compatibility
Group of stents

Versatile & Flexible

  • Full encapsulation with ePTFE offers a barrier to neointimal hyperplasia and helps mitigate the risks related to vessel perforation [1][7]

  • Smooth inner lumen to facilitate the recanalization [1]

  • Able to post-dilate and flare stent: conforming to the anatomy and customizing each patient's treatment [1][9]

  • 316L stainless steel struts provide additional radial force, designed to support the patency of the stent [1]

  • Dog-bone inflation design is intended to reduce the chances of embolization[8]

  • Open-cell stent design provides versatility and flexibility in delivery and placement [1]

Advanta large diameter

Large Diameter

  • Large diameter (12mm) stents with 9 Fr compatibility offers increased treatment options and direct access to aorto-iliac anatomy

  • Expands from 12 to 16 mm

Optimized patient outcomes today, tomorrow and into the future. [3][4][5][6]

COBEST - 5 year results: Advanta V12 vs. Bare Metal Stent [3]

COBEST – randomized multicenter study - Advanta V12 vs. Bare Metal Stent
  • Significantly higher patency in complex TASC C&D lesions compared to bare metal stents at 5 years (p=0.003).
  • Proven two-fold lower reintervention compared to bare metal stents at 5 years post-procedure.
Click here to read more

Systematic review of covered balloon-expandable stents for treating AIOD [2]

  • The Advanta V12/iCast is the only balloon-expandable covered stent to have long-term, real-world follow-up, including a reported 5-year primary patency rate of 74.7%.
  • The Advanta V12/iCast studies treated patients with more severe disease (a greater number of TASC C & D lesions) and more severe symptoms (more Rutherford classification 4 & 5) compared to patients enrolled in clinical trials studying other covered balloon-expandable stents. ​
  • Freedom from TLR: Results were comparable for all CBE stents at 1-year. Advanta V12/iCast is the only CBE stent with current long-term target lesion revascularization data.
Click here to read more
Journal of Vascular Surgery

iCARUS: Single-Arm IDE study with 3-year follow-up [5]

 

 

  • Real-world patient population with multiple lesions and bilateral disease​.
  • Study showed sustained clinical benefit with freedom from Target Lesion Revascularization (TLR) up to 3 years. 
Click here to read more

Pre and post images from occlusive disease treatment with Advanta V12

Bilateral illiac artery occlusion

Bilateral Iliac artery occlusion - pre restoration

Pre treatment

Bilateral Iliac artery occlusion - post restoration

Post treatment

Restoration of the lumen diameter with 10x38 mm Advanta V12 covered stent in RIA; 10x59 mm and 10x38 mm Advanta V12 covered stents overlapped in LIA.

Bilateral common iliac artery occlusion

Bilateral Common Iliac artery occlusion - pre restoration

Pre treatment

Bilateral Common Iliac artery occlusion - post restoration

Post treatment

Restoration of the lumen diameter with 8x59 mm Advanta V12 covered stents in RIA and LIA. 

Renal artery stenosis

Renal artery stenosis - pre restoration

Pre treatment

Renal artery stenosis - post restoration

Post treatment

Restoration of the lumen diameter with Advanta V12 covered stents in LRA.

RIA - Right Iliac Artery, LIA - Left Iliac Artery, LRA - Left Renal Artery, RRA - Right Renal Artery

  1. 1. Data on file.

  2. 2. Mwipatayi, B.P., et al., A systematic review of covered balloon-expandable stents for treating aorto-iliac occlusive disease. Journal of Vascular Surgery, 2020.

  3. 3. Mwipatayi BP, Sharma S, Daneshmand A, et al. Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease. J Vasc Surg. 2016. Jul; 64(1):83-94. Pg 8, paragraph 3. Pg 9, paragraph’s 1, 3, 4.

  4. 4. Harris W, Lesar C, Sprouse L, et al. Covered stents convey improved performance over bare metal stents for artherosclerotic renal artery stenosis. J Vasc Surg. May Suppl. 2013. Pg 1, paragraph 7.

  5. 5. Laird, John R., et al. “iCAST balloon-expandable covered stent for iliac artery lesions: 3-year results from the iCARUS multicenter study.” Journal of Vascular and Interventional Radiology 30.6 (2019): 822-829.

  6. 6. Sabri S, Choudhri A, Orgera G, Arslan B, Turba U, Harthun N, Hagspiel K, Matsumoto A, Angle. Outcomes of Covered Kissing Stent Placement Compared with Bare Metal Stent Placement in the Treatment of Atherosclerotic Occlusive Disease at the Aortic Bifurcation Journal of Vascular and Interventional Radiology, July 2010, Volume 21, Number 7. Pg 1, paragraph 3.

  7. 7. Al-Mukhaini et al., Coronary perforation and covered stents: an update and review; Al-Mukhaini et al., the Official Journal of the Gulf Heart Association; Heart Views. 2011 Apr-Jun.

  8. 8. Grimme et al.; Polytetrafluoroethylene Covered Stent Placement for Focal Occlusive Disease of the Infrarenal Aorta; Eur J Vasc Endovasc Surg (2014).

  9. 9. Riet et al.; Three-Dimensional Geometric Analysis of Balloon-Expandable Covered Stents Improves Classification of Complications after Fenestrated Endovascular Aneurysm Repair; J of Clinical Medicine.

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