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: Cardiva VASCADE® MVP Venous Vascular Closure System (VVCS)
PMA Applicant: Cardiva Medical, Inc.
Address: 2900 Lakeside Drive, #160, Santa Clara, California 95054
Approval Date: November 27, 2018
Approval Letter: Approval Order
What is it? The VASCADE MVP VVCS is a system designed to close puncture sites in large vessels in the leg (femoral vein) following catheterization procedures. Catheterization procedures are commonly used to observe a disease or treat a disease/condition in blood vessels or in the heart. The system is comprised of a collagen patch and a long thin tube used to place the patch (delivery catheter).
The device is a line extension of the VASCADE VCS product family. The ways in which it differs from the original VASCADE VCS product are that it is used in a vein instead of an artery, it can close larger puncture sites, and it can be used in multiple puncture sites in one or both limbs.
How does it work? The health care provider uses the delivery catheter to place the patch inside the punctured tissue between the surface of the skin and the vein (tissue tract). The patch expands to fill the tissue tract, which helps blood clotting and stops blood flow. Over time, the collagen patch breaks down and is absorbed into the body.
When is it used? The VASCADE MVP VVCS system is used to close a puncture site in the blood vessel (femoral vein) in patients who have undergone a procedure for a clinical diagnosis (diagnostic cardiovascular catheter procedure) or a procedure for a treatment, such as to open a blocked coronary artery in the heart with a balloon and place a stent in the opened artery (interventional cardiovascular catheter procedure), using a 6-12F inner diameter procedural sheath.
What will it accomplish? The VASCADE MVP VVCS system may reduce the time for bleeding to stop and may shorten the time for patients to be able to walk after diagnostic and interventional procedures. It may also reduce the length of time it takes for patients to be eligible for discharge from the hospital after diagnostic procedures. In a clinical study, patients treated using the VASCADE® MVP VVCS demonstrated reduced time to walking, total post-procedure time, time to stop bleeding, and time to discharge compared to the standard of care (manual compression).
When should it not be used? The VASCADE® MVP VVCS should not be used in patients with a known allergy to cow derived (bovine) products.
Additional information (including warnings, precautions, and adverse events):