Clinical Data
The Cardiva CATALYST systems are intended to promote hemostasis at arteriotomy sites for patients undergoing diagnostic or interventional femoral artery catheterization procedures. The CATALYST II and CATALYST III systems both work as an adjunct to manual compression to establish hemostasis.
Cardiva CATALYST II supports the body's natural healing process by enhancing the vessel's inherent natural elastic recoil, tissue apposition, and coagulation. With the addition of a protamine sulfate coating, CATALYST III is specifically designed for use with heparinized patients to promote hemostasis at the femoral access site. The protamine sulfate coating acts to locally neutralize heparin and further aid the body's natural hemostatic process.
CATALYST leaves nothing behind, allowing for immediate reaccess if needed.
In a prospective, investigator-initiated clinical study with patients undergoing diagnostic and interventional procedures, CATALYST reduced mean hold time by 50% and time to ambulation by 20%.2
2Data from BOOM II Investigator-Initiated Clinical Study with manuscript submitted for publication. Note: FDA has not reviewed reduced TTH or TTA data.