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ANGIO-SEAL™ VIP - CLINICAL EVIDENCE

SIMPLE. PROVEN. FAST SEALING

2/13/2025 -  

​​​Angio-Seal™ VIP is

  • a bioa​​bsorbable implantable medical device1
  • intended for use in closing and reducing the time to hemostasis of common femoral arterial punctures following arterial access procedures1
  • proven to be safe, effective, and support rapid closure of the femoral access site2


ANGIO-SEAL™ VIP DEMONSTRATED HIGHER DEPLOYMENT SUCCESS RATES VS OTHER VCD​​

  • ​Angio-Seal™ VIP demonstrates high deployment success rates3,4 in diagnostic and interventional settings.​

    • 100% deployment success rate with Angio-Seal™ VIP 6Fr for diagnostic procedures
    • 98.5% deployment success rate with Angio-Seal™ VIP 6Fr for interventional procedures​

  • Angio-Seal™ VIP has demonstrated higher deployment success rate compared to other VCD5



​​ANGIO-SEAL VIP DEMONSTRATED LOWER COMPLICATION RATES VS MANUAL COMPRESSION

  • Angio-Seal™ VIP provides safe, effective, and rapid closure of the femoral access site2
  • Angio-Seal™ VIP has been clinically proven to have significantly lower complication rates than Manual Compression after PCI6​



ANGIO-SEAL VIP REDUCES THE TIME TO HEMOSTASIS

  • Angio-Seal™ VIP is indicated for use in closing and reducing time to hemostasis at the common femoral arterial puncture site1




ANGIO-SEAL VIP REDUCES THE TIME TO AMBULATION

  • Angio-Seal™ VIP is indicated for use to allow patients to ambulate safely as soon as possible after sheath removal and device placement1
  • Angio-Seal™ VIP has clinically proven to reduce time to ambulation7​​




ANGIO-SEAL VIP SUPPORTS EARLY DISCHARGE & COST SAVING​​​

  • Angio-Seal™ VIP is associated with a significantly shorter length of hospital stay compared to manual compression8
  • Compared to manual compression, Angio-Seal™ VIP could lead to cost savings9 after endovascular procedures, despite the additional costs of the VCD itself




ANGIO-SEAL™ VIP IS SAFE TO USE IN ANTEGRADE AND RETROGRADE FEMORAL PUNCTURE10​

  • Angio-Seal™ VIP is a bioabsorbable implantable medical device intended for use in closing and reducing the time to hemostasis of common femoral arterial punctures following arterial access procedures.1 This includes both ANTEGRADE and RETROGRADE punctures.​​​​




ANGIO-SEAL™ VIP & ARTERIAL RESTICK

  • Before considering Angio-Seal™ VIP, a common femoral angiogram of the site is indicated1​

 


ANGIO-SEAL™ VIP & PATIENTS WITH PERIPHERAL VASCULAR DISEASE1

  • If patients have clinically significant PVD, Angio-Seal™ VIP can be deployed safely:​​

    • in patients with arteries >5 mm diameter
    • where there is found to be no luminal narrowing of 40% or greater within 5 mm of the puncture site




​References​
  1. Angio-Seal​ VIP Instruction for use.
  2. Wong H.F. et al. Am J Neuroradiol. 2013; 34: 397-401.
  3. Martin J.L. et al. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):1-5.
  4. Modi S. et al. Indian J Radiol Imaging. 2013;23(2):134-138.
  5. Jones L.E. et al. Ann Vasc Surg. 2018 Aug;51:10-17.
  6. Kreutz R.P. et al J Soc Cardiovasc Angiogr Interv. 2022 Jun 29;1(5).
  7. Alshehri A.M. et al. Int J Angiol. 2015 Jun; 24(2): 133–136.
  8. Veasey R.A. et al. International Journal of Clinical Practice 2008, 62(6), 912–918.
  9. Goueffic Y. et al. Ann Vasc Surg. 2023 Jul;93:64-70
  10. Chaudhuri A. et al. Eur J Vasc Endovasc Surg. 2014 Aug;48(2):220-5.
  11. Ipema J. et al. CRIT LIMB ISCHEM 2023 March 2.
  12. Tellez A.et al. EuroIntervention. 2010 Jan;5(6):731-6.