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Percutaneous Plug-Based Arteriotomy Closure Device for Large-Bore Access: A Multicenter Prospective Study.

Nicolas M Van Mieghem1, Azeem Latib2, Jan van der Heyden3

  • 1Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

JACC. Cardiovascular Interventions
|March 25, 2017
PubMed
Summary

The MANTA Vascular Closure Device (VCD) effectively and safely closes large arteriotomies, achieving rapid hemostasis with low complication rates in complex procedures.

Keywords:
MANTAclosure devicelarge-bore arteriotomy

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Area of Science:

  • Cardiovascular Interventions
  • Medical Device Technology
  • Vascular Surgery

Background:

  • Transfemoral interventions using large-bore catheters offer minimally invasive options but present access site challenges.
  • Currently, no dedicated vascular closure devices are available for large arteriotomies.
  • Managing large arteriotomies is critical for patient safety in advanced percutaneous procedures.

Purpose of the Study:

  • To evaluate the safety and efficacy of the novel collagen-based MANTA Vascular Closure Device (VCD).
  • To assess the performance of the MANTA VCD in closing large arteriotomies resulting from large-bore catheter use.
  • To determine the hemostasis time and complication rates associated with the MANTA VCD.

Main Methods:

  • A prospective, single-arm clinical investigation was conducted across 3 European institutions.
  • Fifty patients undergoing elective percutaneous interventions with large-bore catheters (12-F to 19-F) were enrolled.
  • The MANTA VCD was utilized for percutaneous arteriotomy closure, with deployment success and hemostasis time recorded.

Main Results:

  • The MANTA VCD was successfully deployed in all 50 patients, with no other access site-related complications.
  • Mean time to hemostasis was 2 minutes and 23 seconds.
  • One patient experienced a major vascular and bleeding complication, successfully managed with a covered stent and surgical repair.

Conclusions:

  • The MANTA VCD demonstrates rapid and reliable hemostasis for large-bore arteriotomy closure.
  • This multicenter experience highlights low complication rates with the plug-based MANTA VCD.
  • The MANTA VCD represents a promising solution for managing large arteriotomies in complex cardiovascular interventions.