The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx.
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.
Scheinert
D
D
Department of Angiology, Heart Center, University of Leipzig, Leipzig, Germany. sched@medizin.uni-leipzig.de
Sievert
H
H
Turco
M A
MA
Schmidt
A
A
Hauptmann
K E
KE
Mueller
R
R
Dadourian
D
D
Krankenberg
H
H
Grube
E
E
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
D011092:Polyethylene Glycols