www.fdanews.com/articles/189631-fda-grants-pma-for-cardivas-vascular-closure-device
FDA Grants PMA for Cardiva’s Vascular Closure Device
December 20, 2018
Cardiva Medical has received FDA premarket approval for its Vascade MVP venous vascular closure device, for stopping patient bleeding following electrophysiology procedures.
The device is made up of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc. The disc is used to temporarily stop bleeding from a vessel, after which the patch is inserted and serves as a seal.
The Vascade MVP is specifically intended for multi-site venous closure.