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: MANTA Vascular Closure Device
PMA Applicant: Essential Medical, Inc.
Address: 260 Sierra Drive, Suite 120, Exton, PA 19341 USA
Approval Date: February 1, 2019
Approval Letter: Approval Order
What is it? The MANTA Vascular Closure Device is a system designed to close large puncture sites in one of the large vessels in the leg (femoral artery) following catheterization procedures. The system is a polymer component (toggle) attached to a collagen plug and a delivery system used to place the toggle-collagen plug implant.
How does it work? The surgeon uses the MANTA Vascular Closure Device by placing a toggle-collagen plug in the puncture site in the leg to prevent blood flow. The toggle is released inside the vessel and the collagen is placed outside the vessel. Closure of the access site is achieved by means of the toggle-collagen sandwich.
When is it used? The MANTA Vascular Closure Device is used after the use of large catheters (known as large bore catheters) in catheterization procedures in the femoral artery. The MANTA Vascular Closure Device is used to close the access site after the procedure.
What will it accomplish? The MANTA Vascular Closure Device will seal the opening created by the catheter at the access site. In a clinical study, for patients receiving the MANTA Vascular Closure Device, the average time to stop blood flow at the puncture site was 1 minute.
When should it not be used? There are no known situations in which the MANTA Vascular Closure Device should not be used.
Additional information (including warnings, precautions, and adverse events):