Quick-Close® Vascular Suturing System - P080029
Quick-Close® Suture Applier
Quick-Ti® Cinch Applier
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: Quick-Close® Vascular Suturing System
PMA Applicant: Interventional Therapies, LLC
Address: 1 Gorham Island, Westport, CT 06880
Approval Date: April 8, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080029a.pdf
What is it? The Quick-Close Vascular Suturing System is used to stop the bleeding of a puncture site following a surgical procedure using the major artery of the thigh (femoral artery). It consists of the Quick-Close Suture Applier and the Quick-Ti Cinch Applier. The Suture Applier has a pistol grip shape and contains a single strand of an artificial suture (polybutester [Novafil] ™) fitted with stainless steel rings. The Cinch Applier has a syringe-type shape with an extended handle.
How does it work? The Suture Applier is used to gain access to the puncture site of the femoral artery. Using manual control, and relying on the sense of touch, the device is used to place one end of the suture through one edge of the arterial wound. The Suture Applier is then re-positioned and the other end of the suture is inserted through the opposite edge of the wound site. As the Suture Applier is withdrawn from the wound site, the 24 inch length of suture is forced out of its housing. The Suture Applier places a single stitch of a non-absorbable, single thread suture to the wound site. The Cinch Applier gathers the two ends of the suture and then it places a stainless steel ring that acts in place of a knot to secure the suture in a closed position to stop the bleeding.
When is it used? The Quick Close Vascular Suturing System is used to close a puncture in the femoral artery following surgery. It is designed for use in small vascular punctures in blood vessels with diameters of 4 mm or larger.
What will it accomplish? The Quick-Close Vascular Suturing System is an alternative to applying manual pressure (compression) to stop bleeding. It allows patients to become mobile sooner than is possible with standard compression methods.
When should it not be used? There are no known contraindications for this device.
Additional information: Summary of Safety and Effectiveness and labeling are available online.