The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™
Identifieur interne : 001312 ( Main/Exploration ); précédent : 001311; suivant : 001313The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™
Auteurs : D. Scheinert [Allemagne] ; H. Sievert [États-Unis] ; M. A. Turco [États-Unis] ; A. Schmidt [Allemagne] ; K. E. Hauptmann [Allemagne] ; R. Mueller [Allemagne] ; D. Dadourian [États-Unis] ; H. Krankenberg [Allemagne] ; E. Grube [Allemagne]Source :
- Catheterization and Cardiovascular Interventions [ 1522-1946 ] ; 2007-11-01.
English descriptors
Abstract
Objective: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. Background: The Mynx device is an extra‐arterial vascular closure technology utilizing a water‐soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. Methods: The Mynx study was a prospective, multicenter, single‐arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. Results: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device‐precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). Conclusions: The initial experience with the extra‐arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley‐Liss, Inc.
Url:
DOI: 10.1002/ccd.21353
Affiliations:
- Allemagne, États-Unis
- District de Columbia, District de Leipzig, Hambourg, Maryland, Pennsylvanie, Saxe (Land)
- Hambourg, Leipzig, Washington (district de Columbia)
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Mueller</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg</wicri:regionArea><wicri:noRegion>Siegburg</wicri:noRegion><wicri:noRegion>Siegburg</wicri:noRegion></affiliation></author><author><name sortKey="Dadourian, D" sort="Dadourian, D" uniqKey="Dadourian D" first="D." last="Dadourian">D. Dadourian</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Pennsylvanie</region></placeName><wicri:cityArea>Hahnemann University Hospital, Philadelphia</wicri:cityArea></affiliation></author><author><name sortKey="Krankenberg, H" sort="Krankenberg, H" uniqKey="Krankenberg H" first="H." last="Krankenberg">H. 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Intervent.</title><idno type="ISSN">1522-1946</idno><idno type="eISSN">1522-726X</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007-11-01">2007-11-01</date><biblScope unit="volume">70</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="627">627</biblScope><biblScope unit="page" to="633">633</biblScope></imprint><idno type="ISSN">1522-1946</idno></series><idno type="istex">3FE41F94C39F7106C3FAE31BF99C91E5A48EBAD8</idno><idno type="DOI">10.1002/ccd.21353</idno><idno type="ArticleID">CCD21353</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1522-1946</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>cardiac catheterization</term><term>femoral artery</term><term>hemostasis</term><term>polyethylene glycol</term><term>vascular access</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. Background: The Mynx device is an extra‐arterial vascular closure technology utilizing a water‐soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. Methods: The Mynx study was a prospective, multicenter, single‐arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (±7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. Results: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device‐precipitated complications associated with serious clinical sequelae were reported. Mean (± standard deviation) times to hemostasis and ambulation were 1.3 ± 2.3 min and 2.6 ± 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). Conclusions: The initial experience with the extra‐arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures. © 2007 Wiley‐Liss, Inc.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>États-Unis</li></country><region><li>District de Columbia</li><li>District de Leipzig</li><li>Hambourg</li><li>Maryland</li><li>Pennsylvanie</li><li>Saxe (Land)</li></region><settlement><li>Hambourg</li><li>Leipzig</li><li>Washington (district de Columbia)</li></settlement></list><tree><country name="Allemagne"><region name="Saxe (Land)"><name sortKey="Scheinert, D" sort="Scheinert, D" uniqKey="Scheinert D" first="D." last="Scheinert">D. Scheinert</name></region><name sortKey="Grube, E" sort="Grube, E" uniqKey="Grube E" first="E." last="Grube">E. Grube</name><name sortKey="Hauptmann, K E" sort="Hauptmann, K E" uniqKey="Hauptmann K" first="K. E." last="Hauptmann">K. E. Hauptmann</name><name sortKey="Krankenberg, H" sort="Krankenberg, H" uniqKey="Krankenberg H" first="H." last="Krankenberg">H. Krankenberg</name><name sortKey="Mueller, R" sort="Mueller, R" uniqKey="Mueller R" first="R." last="Mueller">R. Mueller</name><name sortKey="Scheinert, D" sort="Scheinert, D" uniqKey="Scheinert D" first="D." last="Scheinert">D. Scheinert</name><name sortKey="Schmidt, A" sort="Schmidt, A" uniqKey="Schmidt A" first="A." last="Schmidt">A. Schmidt</name></country><country name="États-Unis"><region name="District de Columbia"><name sortKey="Sievert, H" sort="Sievert, H" uniqKey="Sievert H" first="H." last="Sievert">H. Sievert</name></region><name sortKey="Dadourian, D" sort="Dadourian, D" uniqKey="Dadourian D" first="D." last="Dadourian">D. Dadourian</name><name sortKey="Turco, M A" sort="Turco, M A" uniqKey="Turco M" first="M. A." last="Turco">M. A. Turco</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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