The FDA approved the Celt ACD vascular closure device on July 21.
The device, which is developed by Vasorum, is intended for arterial puncture closure in diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients.
The approval was based on results of a randomized trial that enrolled 207 patients who underwent interventional cardiology procedures at four sites in the U.S. and Europe. In Europe, the Celt ACD vascular closure device has been implanted in more than 20,000 patients.
More than eight million catheter procedures are performed each year, according to Vasorum. By 2020, the number of catheter procedures is expected to increase to more than 10 million.
Vasorum expects the device to be available in the U.S. in the third quarter of 2016.