FDA clears next-gen contrast management system for the cath lab
Acist Medical Systems, a Minnesota-based Bracco company, has secured U.S. Food and Drug Administration (FDA) clearance for its Acist Pro Diagnostic System, a next-generation contrast management technology built for the cardiac catheterization lab.
With FDA clearance in place, Acist has officially launched the Acist Pro Diagnostic System in the United States. It already launched in Japan and Europe.
The newly cleared technology includes real-time contrast tracking that helps interventional cardiologists ensure they are meeting the given target limit for every patient. In addition, it includes customizable presets and on-screen troubleshooting that save physicians valuable time.
According to Acist, this new and improved contrast management system helped reduce the use of contrast during interventional procedures, is approximately 33% faster than the previous model and offers up to a 30% reduction in the risk of contrast-induced acute kidney injury. User radiation exposure, meanwhile, is reduced by as much as 96%.
“Expanding access to the Acist Pro System in the United States marks an important milestone for our company and for the future of precision imaging in the cath-lab,” Fulvio Renoldi Bracco, vice-chairman and CEO of Bracco Imaging, said in a statement. “By helping clinicians move from uncertainty to confidence at the point of diagnosis, we are supporting more informed decisions with the goal of improving patient outcomes. We are proud to introduce this solution to the U.S. market and look forward to the positive impact it will have.”
“Clinicians have guided the development of the Acist Pro Diagnostic System every step of the way, reinforcing the need to bring efficiency and physician safety together as a single standard,” added Brad Fox, CEO of Acist Medical Systems. “Designed for precise delivery of contrast media in interventional cardiology, the system streamlines cath lab procedures with consistently clear images. Bringing Acist Pro System to the United States reflects our continued commitment to innovation and to supporting the teams who rely on this technology every day.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.