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MYDOCUMENTS

ANGIO-SEAL® Vascular Closure Devices

Active closure for rapid and reliable hemostasis proven to accelerate patient mobility and enable same-day discharge¹⁻⁶

  • Resorbable components provide safe, effective and rapid closure7,8
  • Lower bleeding complication rates compared to other hemostasis strategies9-12
  • Manual compression not required for reinforcement of the closure13
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RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use. 

References:

  1. Manolis AS, Georgiopoulos G, Stalikas D, Koulouris S. Simplified swift and safe vascular closure device deployment without a local arteriogram: Single center experience in 2074 consecutive patients. Indian Heart J. 2016 Jul-Aug;68(4):529-38. doi: 10.1016/j.ihj.2015.11.036. Epub 2016 Jan 11.
  2. Atonsen L, Jensen LO, Thayssen P. Outcome and safety of same-day-discharge percutaneous coronary interventions with femoral access: A single center experience. Am Heart J 2013; 165:393-9.
  3. Applegate RJ, Turi Z, Sachdev N, Ahmed A, Szyniszewski A, Foster M, Pratsos A, Shapiro T, Yakubov S, Shavelle D. The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device. J Invasive Cardiol. 2010 Sep;22(9):420-6.
  4. Abando A, Hood D, Weaver F, Katz S. The use of the Angioseal device for femoral artery closure. J Vasc Surg. 2004 Aug;40(2):287-90.
  5. Yee KM, Lazzam C, Richards J, Ross J, Seidelin PH. Same-day discharge after coronary stenting: a feasibility study using a hemostatic femoral puncture closure device. J Interv Cardiol. 2004 Oct;17(5):315-20.
  6. Kapadia SR, Raymond R, Knopf W, Jenkins S, Chapekis A, Ansel G, Rothbaum D, Kussmaul W, Teirstein P, Reisman M, Casale P, Oster L, Simpfendorfer C. The 6Fr Angio-Seal arterial closure device: results from a multimember prospective registry. Am J Cardiol. 2001 Mar 15;87(6):789-91, A8.
  7. Nash JE, Evans DG. (1999). The Angio‐Seal hemostatic puncture closure device. Concept and experimental results. Herz, 24(8), 597‐606. http://dx.doi.org/10.1007/bf03044483.
  8. Wong HF, Lee CW, Chen YL, Wu YM, Weng HH, Wang YH, Liu HM. Prospective comparison of angio-seal versus manual compression for hemostasis after neurointerventional procedures under systemic heparinization. AJNR Am J Neuroradiol. 2013 Feb;34(2):397-401. doi: 10.3174/ajnr.A3226. Epub 2012 Aug 2.
  9. Resnic FS, Majithia A, Marinac-Dabic D, Robbins S, Ssemaganda H, Hewitt K, Ponirakis A, Loyo-Berrios N, Moussa I, Drozda J, Normand SL, Matheny ME. Registry-Based Prospective, Active Surveillance of Medical-Device Safety. N Engl J Med. 2017 Feb 9;376(6):526-535. doi: 10.1056/NEJMoa1516333. Epub 2017 Jan 25.Gregory D, Midodzi W, Pearce N. Complications with Angio-Seal™ vascular closure devices compared with manual compression after diagnostic cardiac catheterization and percutaneous coronary intervention. J Interv Cardiol. 2013 Dec;26(6):630-8.
  10. Gregory D, Midodzi W, Pearce N. Complications with Angio-Seal™ vascular closure devices compared with manual compression after diagnostic cardiac catheterization and percutaneous coronary intervention. J Interv Cardiol. 2013 Dec;26(6):630-8.
  11. Tavris DR, Wang Y, Jacobs S, Gallauresi B, Curtis J, Messenger J, Resnic FS, Fitzgerald S. Bleeding and vascular complications at the femoral access site following percutaneous coronary intervention (PCI): an evaluation of hemostasis strategies. J Invasive Cardiol. 2012 Jul;24(7):328-34. Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices Am Heart J. 2007 Apr; 153 (4): 606-11.
  12. Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices Am Heart J. 2007 Apr; 153 (4): 606-11.
  13. ANGIO-SEAL VIP Instructions for Use, ASIN0004 revision 2018-09-01.
  14. Data on file.


Indications:
The  Angio-Seal Vascular Closure Device product family, including the STS Plus, VIP and Evolution platforms, is indicated for use in closing and reducing time to hemostasis of the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures or interventional procedures using an 8 French or smaller procedural sheath for the 8 F Angio-Seal device and a 6 French or smaller procedural sheath for the 6 F Angio-Seal device. The Angio-Seal STS Plus, VIP and Evolution platform devices are also indicated for use to allow patients who have undergone diagnostic angiography to safely ambulate as soon as possible after sheath removal and device placement, as well as to allow patients who have undergone an interventional procedure to safely ambulate after sheath removal and device placement.

Important Safety Information:
Possible adverse events for vascular closure devices include, but are not limited to: bleeding or hematoma, AV fistula or pseudoaneurysm, infection, allergic reaction, foreign body reaction, inflammation or edema. This device should only be used by a licensed physician (or other health care professional authorized by or under the direction of such physician) possessing adequate instruction in the use of the device, e.g., participation in an Angio-Seal physician instruction program or equivalent.