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iCast covered stent system

Clinical Confidence[1]

iCast Covered Stent
Advanta V12 Balloon Expandable Covered Stent

iCast covered stent system

The iCast covered stent system 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 iCast covered stent system has been meeting the needs of surgeons and patients for 20 years.[2][3] 

Indication:

The iCast covered stent system is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the native common and/or external iliac arteries up to 110 mm in length, with a reference vessel diameter of 5 to 10 mm.

The iCast covered stent system is not available outside of the United States.

 

 

Bilateral common iliac restenosis remodeled with the iCast covered stent system 

Predictable and Precise

  • Low profile, high stent retention force and secure trackability facilitates stent implantation[1]
  • Designed for secure delivery placement: Average stent securement force is 2-4 times higher than peak insertion forces
  • 6 and 7 French compatible
  • Enhanced visibility with radiopaque markers enables accurate stent placement during deployment [1]
  • Designed for pushability and trackability through tortuous anatomy with conformance to iliac arteries [1]
  • Predictable recoil and foreshortening provides precise deployment [1]

Please see the iCast order information found in the documents tab for detailed compatibility. 

Refer to Instructions for Use for current indications, warnings, contraindications, and precautions. 

Group of stents

Versatile and Flexible

  • Full encapsulation with ePTFE offers an effective barrier to neointimal hyperplasia and helps mitigate the risks related to vessel perforation [1][7]
  • Smooth inner lumen to facilitate 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 necessary radial force for the durability of indicated treatments – adding long-term patency [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]

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

  • 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%.[4]
  • Proven two-fold less reintervention compared to bare metal stents at 5 years[4]

COBEST -   5 year results: iCast vs. Bare Metal Stent

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).[4]
  • Proven two-fold lower reintervention compared to bare metal stents at 5 years post-procedure. [4]

Systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease [3]

  • The iCast/Advanta V12[2] 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 iCast/Advanta V12 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 covered balloon-expandable stents at 1-year. iCast/Advanta V12 is the only covered balloon-expandable stent with current long-term target lesion revascularization data.

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

iCarus 3years study results

Freedom from Target Lesion Revascularization (TLR)​

  • 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 [5] 

Pre and post images from occlusive disease treatment with iCast covered stent system

 

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 iCast covered stent in RIA. iCast covered stents overlapped in LIA.

RIA: Right iliac artery
LIA: Left iliac artery

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 iCast covered stents in RIA and LIA.

RIA: Right iliac artery
LIA: Left iliac artery

  1. 1. 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;64(1):83-94.e1. doi:10.1016/j.jvs.2016.02.064. (Mwipatayi BP, et al. showed less restenosis when comparing Advanta V12 covered stent to bare metal stent in TASC C and D through 5 years. )

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  2. 2. Both Advanta V12 and iCast covered stent systems are manufactured by Atrium Medical Corporation. Advanta V12 is available outside of the United States. iCast is available only in the United States. Both products are the same physical stent and delivery system under different brands. Duration of use, number of units, and publications are combined Advanta V12 and iCast records. Data on file.

  3. 3. Mwipatayi BP, Ouriel K, Anwari T, et al. A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease. J Vasc Surg. 2020;72(4):1473-1486.e2. doi:10.1016/j.jvs.2020.01.084.

    View on PubMed
  4. 4. 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;64(1):83-94.e1. doi:10.1016/j.jvs.2016.02.064. Pg 8, paragraph 3. Pg 9, paragraph’s 1, 3, 4.

    View on PubMed
  5. 5. Laird JR, Loja M, Zeller T, et al. iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study. J Vasc Interv Radiol. 2019;30(6):822-829.e4. doi:10.1016/j.jvir.2018.12.707.

    View on PubMed
  6. 6. Sabri SS, Choudhri A, Orgera G, et al. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. J Vasc Interv Radiol. 2010;21(7):995-1003. doi:10.1016/j.jvir.2010.02.032. Volume 21, Number 7. Pg 1, paragraph 3.

    View on PubMed
  7. 7. Al-Mukhaini M, Panduranga P, Sulaiman K, Riyami AA, Deeb M, Riyami MB. Coronary perforation and covered stents: an update and review. Heart Views. 2011;12(2):63-70. doi:10.4103/1995-705X.86017.

    View on PubMed
  8. 8. Grimme FA, Reijnen MM, Pfister K, Martens JM, Kasprzak P. Polytetrafluoroethylene covered stent placement for focal occlusive disease of the infrarenal aorta. Eur J Vasc Endovasc Surg. 2014;48(5):545-550. doi:10.1016/j.ejvs.2014.08.009.

    View on PubMed
  9. 9. van der Riet C, Schuurmann RCL, Verhoeven ELG, et al. Three-Dimensional Geometric Analysis of Balloon-Expandable Covered Stents Improves Classification of Complications after Fenestrated Endovascular Aneurysm Repair. J Clin Med. 2022;11(19):5716. Published 2022 Sep 27. doi:10.3390/jcm11195716.

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