This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Mynx™ Vascular Closure System (VCS)
PMA Applicant: AccessClosure, Inc.
Address: 645 Clyde Avenue, Mountain View, CA 94043
Approval Date: May 16, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040044s001a.pdf
What is it? The Mynx™ VCS is vascular closure system designed to seal a puncture site in the femoral artery and stop the bleeding after a cardiac catheterization procedure. The Mynx™ VCS uses a balloon catheter and a standard procedural sheath to deliver an extravascular, hydrogel sealant used to seal the puncture site.
How does it work?
- Following the cardiac catheterization procedure, the Mynx™ VCS balloon catheter is inserted through the introducer sheath into in a blood vessel in the leg (the femoral artery) to temporarily stop bleeding at the puncture site.
- They hydrogel sealant is injected through the introducer sheath at the puncture site and within the tissue tract that stops the bleeding and seals the access site.
- Once sealed, the balloon catheter is deflated and removed along with the introducer sheath and manual compression is applied for 1-2 minutes to ensure bleeding stops.
- The gel will absorb into the body within 30 days.
When is it used? It is used on patients who have undergone diagnostic or interventional endovascular procedures
What will it accomplish? The Mynx is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation utilizing a 5F, 6F or 7F procedural sheath.
When should it not be used? ? There are no known contraindications for Mynx.
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040044s001