title: The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx.
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.
authors.affiliation: Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany. sched@medizin.uni-leipzig.de
authors.forename: D
authors.initials: D
authors.lastname: Scheinert
authors.forename: H
authors.initials: H
authors.lastname: Sievert
authors.forename: M A
authors.initials: MA
authors.lastname: Turco
authors.forename: A
authors.initials: A
authors.lastname: Schmidt
authors.forename: K E
authors.initials: KE
authors.lastname: Hauptmann
authors.forename: R
authors.initials: R
authors.lastname: Mueller
authors.forename: D
authors.initials: D
authors.lastname: Dadourian
authors.forename: H
authors.initials: H
authors.lastname: Krankenberg
authors.forename: E
authors.initials: E
authors.lastname: Grube
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D016062:Porosity; D011183:Postoperative Complications; D011446:Prospective Studies; D011677:Punctures; D013525:Surgical Instruments; D016896:Treatment Outcome
chemical_list: D011092:Polyethylene Glycols