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The duett™ closure device: Concept and experimental results

Das Duett™-Verschlußsystem: Konzept und experimentelle Ergebnisse

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Abstract

Purpose of this paper is to investigate the hemostatic capabilities of a novel vascular sealing device consisting of a balloon catheter and procoagulant.

Vascular sheaths were placed percutaneously in the femoral arteries of dogs. The sealing device was evaluated using the balloon catheter alone in 6 femoral arteries and with the addition of a procoagulant in 21 femoral arteries.

The balloon catheter alone was successfully deployed in 6 of 6 femoral arteries achieving immediate hemostasis. In a second study in which the procoagulant was delivered following balloon placement, the sealing device was successfully deployed and hemostasis was achieved in 20 of 21 attempts (95%) despite removal of the balloon catheter. In a subset of fully anticoagulated animals, hemostasis was achieved in the sealing device-treated arteries at 6.5±3.4 minutes but in none of the controls (p<0.001).

This novel vascular sealing device successfully achieves rapid hemostasis in normal and anticoagulated dogs following percutaneous vascular procedures.

Zusammenfassung

Ziel dieser Arbeit ist es, die hämostatischen Eigenschaften des neuen arteriellen Verschlußsystems, welches im wesentlichen aus einem Ballonkatheter und einer prokoagulatorischen Mischung besteht, zusammenfassend darzustellen.

Das Verschlußsystem wurde experimentell an Hunden geprüft: Nach Einführen einer Schleuse in die Arteria femoralis wurde der Ballonkatheter des Verschlußsystems in sechs Femoralarterien und mit zusätzlicher Verwendung der prokoagulatorischen Mischung in 21 Femoralarterien untersucht.

Der Ballonkatheter wurde in allen sechs Femoralarterien erfolgreich eingesetzt, so daß bei Aufdehnung des Ballons die Hämostase sofort eintrat. In einer zweiten Studie mit zusätzlicher Gabe der prokoagulatorischen Mischung konnte eine erfolgreiche Hämostase bei 20 der 21 Anwendungen (95%) erzielt werden, obwohl der Ballonkatheter entfernt wurde. In einer Untersuchungsreihe an voll antikoagulierten Tieren konnte eine Hämostase mit dem neuen Verschlußsystem nach 6,5±3,4 Minuten erzielt werden, jedoch nicht bei den Kontrolltieren (p<0,01).

Somit führt dieses neue Verschlußsystem bei normalen und antikoagulierten Hunden nach perkutanen vaskulären Eingriffen zu einer raschen Hämostase.

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Authors and Affiliations

  1. John Muir Medical Center, Walnut Creek, California, USA

    Gary Gershony MD, FACC

  2. Vascular Solutions, Inc., Minneapolis, Minnesota, USA

    Todd Jensen

Authors
  1. Gary Gershony MD, FACC
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  2. Todd Jensen
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Correspondence to Gary Gershony MD, FACC.

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Gershony, G., Jensen, T. The duett™ closure device: Concept and experimental results. Herz 24, 614–619 (1999). https://doi.org/10.1007/BF03044485

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  • DOI: https://doi.org/10.1007/BF03044485

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