A Medical Device Daily
Cardiva Medical (Mountain View, California) said that it has received FDA clearance for its latest technology, the Cardiva Catalyst III, which is considered the first drug coated vessel closure device in the market.
The 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 quick and efficient 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. Cardiva estimates that annually 1.7 million patients in the U.S. receive heparin during an endovascular procedure; the majority of these cases are for peripheral vascular disease, the fastest growing segment in the percutaneous procedure market.
Cardiva makes endovascular products which are designed to help the body heal itself.