Abbott has announced that the US Food and Drug Administration (FDA) has approved the company’s Portico with FlexNav transcatheter aortic valve implantation (TAVI) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.
“For people in the USA suffering from aortic stenosis and unable to have surgery, the Portico with FlexNav system offers a safe and effective treatment option,” said Raj Makkar, associate director of Interventional Technologies at Cedars-Sinai’s Smidt Heart Institute, Los Angeles, USA who served as co-principal investigator for the study that led to FDA approval. Gregory Fontana, national director, Cardiothoracic Surgery at Hospital Corporation of America and American Research Institute, also served as co-principal investigator of the Portico IDE study.
Portico is a self-expanding TAVI valve with intra-annular (within the native valve) leaflets that help provide optimal blood flow (haemodynamics) when placed inside a patient’s natural valve. The structure of the replacement valve also preserves access to the critical coronary arteries for future coronary interventions, Abbott said in a press release. The Portico device is implanted using Abbott’s FlexNav delivery system, which features a slim design to accommodate different patient anatomies and small vessels, and optimizes flexibility, ease of tracking and precision of valve placement.
“With the approval of our TAVI therapy in the USA, physicians now have access to an even more robust set of solutions to treat structural heart disease,” said Michael Dale, senior vice president of Abbott’s structural heart business. “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.”