FDA Approves Vasorum's Celt ACD Vascular Closure Device

July 21, 2016—Vasorum Ltd. announced US Food and Drug Administration approval of the Celt ACD vascular closure device, which is indicated for arterial puncture closure in both diagnostic and anticoagulated percutaneous interventional cardiology and interventional radiology procedures. The company anticipates a United States launch of the device in the third quarter of 2016. The Celt ACD has previously received CE Mark approval and is commercially available in Europe. 

Celt ACD is a single-use femoral artery puncture closure device in three sizes for closure of 5-, 6-, and 7-F punctures. The device allows physicians to perform multiple restick procedures and addresses a broad range of clinical situations and patient anatomies, stated the company.

According to Vasorum, which is based in Ireland, the Celt ACD is supported by a randomized controlled clinical trial that recruited 207 patients undergoing interventional cardiology procedures at four centers in the United States and Europe. The trial's Principal Investigator was Shing-Chiu Wong, MD, Director of Cardiac Catheterization at the New York-Presbyterian/Weill Cornell Medical Center in New York, New York. 

In the company’s announcement, Dr. Wong commented that he “was very pleased with the positive outcome of the clinical trial, which shows that Celt ACD can help in addressing the clear need for quicker and more efficient methods of increasing patient throughput in health care facilities.”