Vasorum Ltd. Receives FDA Approval for Celt ACDŽ Vascular Closure Device
12:50Vasorum Ltd.
The developer and manufacturer of the novel Celt ACDŽ vascular closure device has received approval of its PMA application from the US Food and Drug Administration (FDA).
Celt ACDŽ, which previously received CE mark and is sold in Europe, is indicated for arterial puncture closure in both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients.
Celt ACDŽ offers excellent time to hemostasis in a wide variety of clinical situations.
A randomized controlled clinical trial which recruited 207 interventional cardiology procedure patients was carried out in four International Cardiology Centres across US and Europe.
The trial's Principal Investigator was Dr.
Shing-Chiu Wong, Director of Cardiac Catheterization at the NewYork-Presbyterian/Weill Cornell Medical Center.
Dr Wong commented that he "was very pleased with the positive outcome of the clinical trial which shows that Celt ACDŽ can help in addressing the clear need for quicker and more ...
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