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FDA approves device to close large-bore vascular punctures
The FDA announced that it recently approved a device to close large-bore puncture sites used to obtain vascular access in catheter-based procedures such as abdominal aortic aneurysm repair, transcatheter aortic valve replacement and balloon aortic valvuloplasty.
The vascular closure device (Manta, Teleflex/Essential Medical) has a toggle/collagen plug implant that is placed with a delivery system, according to an update from the FDA.
The toggle is released inside the vessel, the collagen plug is placed outside the vessel and “closure of the access site is achieved by means of the toggle-collagen sandwich,” according to the update.
In a clinical study, average time to stop blood flow at the puncture side was less than 1 minute, according to the update.