Large-Bore Vascular Closure Device Cleared by the FDA

Essential Medical Inc. received U.S. Food and Drug Administration (FDA) clearance for its large bore Manta Vascular Closure Device. It is designed to close large puncture sites in the femoral artery from larger sized transcatheter devices, including the Impella heart pump, endovascular stent grafts and transcatheter valves.

April 3, 2019 — Essential Medical Inc. received U.S. Food and Drug Administration (FDA) clearance for its large bore Manta Vascular Closure Device. It is designed to close large puncture sites in the femoral artery from larger sized transcatheter devices, including the Impella heart pump, endovascular stent grafts and transcatheter valves.

Following catheterization procedures, the device uses a polymer toggle attached to a collagen plug and a delivery system used to place the toggle-collagen plug to seal the vascular access site. 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. The FDA said in a clinical study, for patients receiving the Manta device had an average hemostasis time of about 1 minute.

Watch the VIDEO: How to Achieve Hemostasis With Large Bore Device Access — an interview with Philippe Genereux, M.D. about the Manta device.

For more information: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm631393.htm?utm_campaign=2019-03-25%20Recently%20Approved%20Devices&utm_medium=email&utm_source=Eloqua