The device, which earlier secured CE mark approval, has been developed for arterial puncture closure in both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients.
Celt ACD will be used for closure of 5F, 6F and 7F punctures. It will enable physicians to carry out multiple re-stick procedures and address a wide range of clinical situations and patient anatomies.
The safety and efficacy of Celt ACD was demonstrated in a 207-patient randomized controlled clinical trial that was carried out in four International Cardiology Centres across US and Europe.
The trial’s principal investigator Shing-Chiu Wong said 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 healthcare facilities."
The company intends to launch Celt ACD femoral artery puncture closure device in the US market place in the third quarter of this year.
Vasorum co-founder and CEO James Coleman said: "With more than 20,000 patient implants 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 FDA approval is a very significant milestone allowing US market entry by Vasorum.”
Image: Celt ACD vascular closure device is indicated for arterial puncture closure in anticoagulated percutaneous interventional cardiology and radiology patients. Photo: PRNewsFoto/Vasorum Ltd.
