Following FDA approval of its PMA supplement, Vasorum has added a 7F Celt ACD vascular closure device to its Celt ACD 6F and Celt ACD 5F range in the USA.
Celt ACD is indicated for arterial puncture closure in both diagnostic and interventional cardiology and radiology patients. Celt ACD offers “excellent time to haemostasis in a wide variety of clinical situations,” a company press release says. The second generation Celt ACD devices, now available in both the USA and Europe, have a newly improved delivery system which has been designed to enhance the user experience during deployment.
The first commercial cases in the USA were carried out by Shing-Chiu Wong, Professor of Medicine at Weill Cornell Medicine in New York. Based on his use, Wong commented, “The Celt ACD range of closure devices are addressing the clear need for quicker and more efficient methods of increasing patient throughput in healthcare facilities, and they provide doctors and patients with a solution which can efficiently manage arterial closure following vascular procedures.” Clinical cases have also been carried out by Richard Kovach, Division Director, Interventional Cardiology and Medical Director, Cardiac Catheterization Laboratory at Deborah Heart and Lung, Browns Mills, New Jersey. Kovach commented that he “was impressed with the performance of Celt ACD in patients with severe arterial disease undergoing complex interventional procedures.” Additionally, he believes that “Celt ACD has the potential to become the workhorse closure device in cath labs.”
There are currently over 8 million catheter procedures performed annually, which support an estimated US$1bn femoral artery closure device market. The number of procedures is expected to exceed 10 million by 2020. In addition to interventional cardiology procedures, the market growth is being driven by an increasing number of peripheral vascular, neurovascular and other catheter procedures which demand more patient-friendly devices and more efficient patient discharge from hospitals. Given its ease of use and wide clinical applicability, Celt ACD is well positioned to address this broad and growing market opportunity.
“To date in Europe, Celt ACD has proven itself to be a best in class arterial puncture closure device. Celt ACD allows immediate closure of multiple re-sticks in calcified vessels and is also very comfortable for patients. The launch of the expanded Celt ACD range in the USA is a very significant milestone for Vasorum,” stated James Coleman, co-founder and CEO of Vasorum.