Interventional Therapies receives CE mark on Quick-Close® II

(I-Newswire) September 17, 2010 - WESTPORT, CT: Interventional Therapies announced today that it received CE mark for its advanced second generation Quick-Close II.

The Quick-Close® II is the second generation of the FDA approved and CE marked Quick-Close® vascular closure device. It features ergonomic enhancements, increased ease of use, reduced learning curve and increased adoption rates. 
Quick-Close® is approved for use in femoral arteriotomy closure in both diagnostic and interventional endovascular procedures using 5F to 8F sheaths. Quick-Close®, by design, allows for simple, verifiable, and consistently safe vascular closure with the additional safety of a monfiloment suture closure. The device allows the user to have a safety check at each step, ensuring proper percutaneous placement and function. Quick-Close® requires less deployment steps and user dexterity than existing devices. 
Quick-Close® has proven to significantly reduce time-to-hemostasis and time-to-ambulation. In the Quick-Close® pivotal trial involving 367 patients, median time-to-hemostasis was one minute. 
“We are pleased with the continued progress of the vascular closure product line,” said Bob Knarr, President and CEO of Interventional Therapies. “The second generation VCD forms the foundation for the Quick-Close® Multi-Close™ device, uniquely designed for percutaneous large bore closures of arteriotomies up to 24F.” 

Quick-Close® Vascular Suturing System

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.