Abbott Perclose ProGlide Suture-Mediated Closure System - P960043/S097
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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Perclose ProGlide Suture-Mediated Closure System
PMA Applicant: Abbott Vascular
Address: 3200 Lakeside Avenue, Santa Clara, CA 95054 US
Approval Date: February 16, 2018
Approval Letter: Approval letter
What is it? The Perclose ProGlide Suture-Mediated Closure System is composed of a plunger, handle, guidewire, and sheath. The device is designed to deliver a single suture (stitch) to close the puncture sites (access sites) in large vessels in the leg (femoral vein or artery) following catheterization procedures. Catheterization procedures are commonly used to observe or treat a disease/condition in blood vessels or in the heart. During these procedures, an opening may be made in the femoral vein or artery to insert a catheter (flexible tube). After the procedure is finished, the catheter is removed. The placement of a suture where the catheter was inserted will prevent blood flow until the access site heals.
How does it work? The surgeon places the ProGlide over a guidewire and inserts the end of the device into the blood vessel. The surgeon presses the plunger and lever on the handle of the device, which maneuver the suture to create a stitch across the access site. In some cases (3 out of 10), in addition to the ProGlide stitch, pressure may need to be applied to the access site to fully stop blood flow. When catheters larger than about 0.1 inches in diameter are used during the catheterization procedure, two ProGlide devices are necessary to close the access site.
When is it used? The ProGlide is used after the insertion of large catheters (known as large bore catheters) in catheterization procedures in the femoral vein or artery. The ProGlide is able to close access sites ranging from about 0.07 inches to 0.32 inches in diameter.
What will it accomplish? The ProGlide will seal the opening created by the catheter at the access site either with or without additional pressure applied to the stop blood flow.
When should it not be used? There are no known situations in which the Perclose ProGlide Suture-Mediated Closure System should not be used.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.