New TAVR system for high-risk patients gains FDA approval
Abbott’s Portico with FlexNav transcatheter aortic valve replacement (TAVR) system has gained FDA approval. The system was specifically designed for treating patients who it is believed should avoid open-heart surgery.
Announcing the news on Monday, Sep. 20, Abbott detailed the Portico system’s intra-annular leaflets and noted that its replacement valve makes it possible to carry out future coronary interventions if necessary.
“With the approval of our TAVR therapy in the U.S., physicians now have access to an even more robust set of solutions to treat structural heart disease,” Michael Dale, senior vice president of Abbott's structural heart business, said in a prepared statement. “This latest and important introduction of Portico with FlexNav represents another milestone in our work to advance our mission to restore health and improve quality of life so more people can get back to living fuller lives.”
“For people in the U.S. suffering from aortic stenosis and unable to have surgery, the Portico with FlexNav system offers a safe and effective treatment option,” added Raj Makkar, MD, associate director of interventional technologies at Cedars-Sinai's Smidt Heart Institute and co-principal investigator of an analysis into the system’s efficacy.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.