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: Matrix VSG™ System
Manufacturer: AccessClosure, Inc.
Address: 645 Clyde Avenue, Mountain View, California 94043
Approval Date: August 17, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040044a.pdf
What is it? The Matrix VSG™ System is used to seal a puncture site in the femoral artery and stop bleeding after a cardiac catheterization procedure. The Matrix VSG™ System uses a balloon catheter and two polymer powders that are mixed together to form a polyethylene glycol (PEG) gel that is injected at the puncture site.
How does it work?
- Following the cardiac catheterization procedure, the Matrix VSG™ 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.
- Two polymer powders are mixed and injected through the introducer sheath to form a gel of polyethylene glycol (PEG) polymer at the puncture site and within the tissue tract that stops the bleeding.
- After delivery of the polymer 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? The Matrix VSG™ System is used following a cardiac catheterization procedure. For an illustrated explanation of cardiac catheterization, use the following link: http://www.nlm.nih.gov/medlineplus/ency/imagepages/1080.htm
What will it accomplish? The Matrix VSG™ System uses a polymer gel to cover and seal the puncture site in the femoral artery. Without this or a similar device, manual compression is applied to the puncture site to stop the bleeding. The Matrix VSG™ System allows patients to get out of bed and walk sooner than is possible with standard compression methods.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040044