EVALUATION STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
Add like
Add dislike
Add to saved papers

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.

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app