The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx

Catheter Cardiovasc Interv. 2007 Nov 1;70(5):627-33. doi: 10.1002/ccd.21353.


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.

Publication types

  • Evaluation Study
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization / instrumentation*
  • Equipment Design
  • Equipment Safety
  • Europe
  • Female
  • Femoral Artery / surgery*
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Polyethylene Glycols
  • Porosity
  • Postoperative Complications
  • Prospective Studies
  • Punctures
  • Surgical Instruments*
  • Treatment Outcome


  • Polyethylene Glycols