Vasorum said today that it won pre-market approval from the FDA for its Celt ACD vascular closure device.
The Dublin-based company said the Celt ACD is designed to close punctures to the femoral artery after catheterization, using a biocompatible implant on both the inside and outside of the arterial wall.
Vasorum said the PMA approval was based on a 207-patient trial in the U.S. and Europe led by Dr.Shing-Chiu Wong of the NewYork-Presbyterian/Weill Cornell Medical Center.
The device has already won CE Mark approval in the European Union, Vasorum 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 U.S. market entry by Vasorum,” co-founder & CEO Dr. James Coleman said in prepared remarks.