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Vascular closure device approved for US market by FDA
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Vasorum Ltd. announced that its vascular closure device has been approved by the FDA for use in interventional cardiology and interventional radiology procedures.
The device (Celt ACD) is indicated for arterial puncture closure in patients undergoing diagnostic or anticoagulated percutaneous interventional cardiology or radiology procedures, according to a press release issued by the company.
The device, which previously received a CE mark, “is well positioned to address” a “broad and growing market opportunity,” the company stated in the release, noting that the femoral artery device closure market is estimated at $1 billion, with 8 million procedures performed per year, a figure that could grow to 10 million by 2020.
Approval was based on a randomized controlled trial of 207 patients undergoing interventional cardiology procedures, which compared the device to manual compression in 30-day major complication rate and time to hemostasis, according to the release and the trial’s page at clinicaltrials.gov.
Shing-Chiu Wong, MD, director of cardiac catheterization at NewYork-Presbyterian/Weill Cornell Medical Center, who served as principal investigator of the trial, said in the release 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.”
Disclosure: Wong reports serving as principal investigator of a trial sponsored by Vasorum.