Perclose ProGlide Suture-Mediated Closure System (ProGlide SMC) – P960043/S080
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 (ProGlide SMC)
PMA Applicant: Abbott Vascular
Address: Abbott Vascular Inc., 400 Saginaw Drive, Redwood City, CA 94063
Approval Date: April 15, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p960043s080a.pdf
What is it? The Perclose ProGlide Suture-Mediated Closure (ProGlide SMC) System is designed to deliver a single monofilament polypropylene suture to close a femoral artery (a major artery in the thigh) puncture site following diagnostic or interventional catheterization procedures.
How does it work? The Perclose ProGlide SMC System is used to deliver a suture to close the femoral artery site. It is composed of a plunger, handle, guide, and sheath. The ProGlide SMC System tracks over a standard four-tenths (0.4) of an inch (or smaller) guidewire.
A hemostasis (the process that stops bleeding) valve limits the blood flow through the sheath with or without the guidewire in place. The guide houses the needles and the foot, and precisely controls the placement of these needles around the puncture site. The handle keeps the device steady during use. The plunger advances the needles and retrieves the suture. Within the guide there is a tabular structure (a marker lumen) that has its opening positioned at the far end of the guide. At the point nearest the guide, the marker lumen exits from the body of the device. The marker lumen allows a pathway for bleeding that backflows from the femoral artery to ensure proper device positioning.
When is it used?
The ProGlide SMC System is used to deliver a suture to close the femoral artery site for patients who have undergone diagnostic or interventional catheterization procedures such as minimally invasive cardiac surgery, cardiopulmonary bypass, isolated balloon aortic valvuloplasty (BAV), transcatheter aortic valve implantation (TAVI), and percutaneous thoracic endovascular aortic aneurysm repair (PTEVAR) using 5F to 21F (1.7 millimeters to 21 millimeters, or .17 inch to .28 inch) sheaths.
What will it accomplish? The ProGlide SMC System delivers a suture at the femoral artery access site, closing a site that is up to and including 21F in sheath size, and results in a shorter procedure time and a shorter time to achieve hemostasis.
When should it not be used? Do not use the Perclose ProGlide SMC System if:
- The puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma (a pocket of blood found in the lower back in an area known as the retroperitoneal space).
- The puncture is through the back part of the wall or if there are multiple punctures, since such punctures may result in a hematoma or retroperitoneal bleed.
- The puncture site is located in the superficial femoral artery or the profunda femoris artery (a branch of the femoral artery that travels more deeply), or the bifurcation (splitting into two parts) of these vessels, since such puncture sites may result in a pseudoaneurysm (a hematoma that forms as the result of a leaking hole in an artery), intimal (innermost membrane) dissection, or an acute vessel closure (thrombosis – a formation of a blood clot inside a blood vessel of a small artery lumen).
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.