Cardiva drug-coated vessel closure device nets FDA clearance

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Cardiva Medical has received clearance from the FDA for its Catalyst III, which is a drug-coated vessel closure device.

The Mountain View, Calif.-based company said its Catalyst III is coated with protamine sulfate, a drug which neutralizes heparin in the tissue adjacent to the device. Local heparin reversal by the Catalyst III system facilitates vessel closure as an adjunct to manual compression in patients undergoing anticoagulation with heparin. Catalyst III's protamine coating contacts the tissue tract from the arteriotomy site to the point of percutaneous entry in the skin.