Irish devicemaker Vasorum got FDA approval for its Celt ADC vascular closure device that is aimed at arterial puncture closure.
The device is indicated for both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients. A study of 207 interventional cardiology procedure patients that was conducted in four cardiology centers in the U.S. in Europe helped support the approval, the company 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,” Dr. James Coleman, co-founder and CEO of Vasorum, said in a statement. He added that the device “allows immediate closure of multiple re-sticks in calcified vessels and is also very comfortable for patients.”
More than 8 million catheter procedures are performed annually, which pegs the femoral artery closure device market at about $8 billion, the company estimated.
The number of procedures is expected to surpass 10 million in the next four years. On top of the number of interventional cardiology procedures, growth is also being fueled by more peripheral vascular, neuro-vascular and other catheter procedures that require more patient friendly devices and more efficient patient discharge from hospitals.
Cardiva Medical and Cardinal Health are also is a players in the vascular closure device arena.
-here’s the release