Irish medical device research and development firm Vasorum has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its arterial puncture closure device Celt ACD to be used for both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients.
Celt ACD comes in three sizes and is meant for a single-use. It offers a safe and effective closure of 5F, 6F and 7F arterial punctures
The design of the device features versatility which enables the physicians to conduct multiple re-stick procedures thereby treating a wide range of clinical situations and patient anatomies.
The device also facilitates a fast and definitive closure procedure allowing an earlier ambulation of the patient, thereby aiding in promoting an efficient workflow in the cath lab.
Vasorum CEO and co-founder 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."
A randomised controlled clinical trial of Celt ACD was conducted in US and Europe involving 207 interventional cardiology procedure patients.
The trial reported a positive outcome in which thedevice had displayed a quick and efficient operation in the healthcare facilities.
Image: Vasorum’s Celt ACD device. Photo: courtesy of PRNewsFoto / Vasorum Ltd.