Harmony TPVR System Gains CE Mark Approval
Harmony TPVR System Gains CE Mark Approval.
6 January2025
The Harmony transcatheter pulmonary valve replacement (TPVR) system received CE mark approval, allowing it to be marketed across the European Union. This minimally invasive alternative to open-heart surgery is designed for patients with congenital heart disease suffering from severe pulmonary regurgitation. The system was previously approved by the U.S. Food and Drug Administration (FDA) in 2021. It faced a voluntary recall in 2022 due to durability issues but was relaunched within a year.
Regarding other transcatheter valve replacements, transcatheter aortic valve replacement (TAVR) is widely used for treating aortic valve stenosis without open-heart surgery. Advances are also being made in transcatheter mitral and tricuspid valve replacements, offering less invasive treatment options for patients.
https://cardiovascularbusiness.us13.list-manage.com/track/click?u=ede357a4dde4e6d1363fede03&id=7ea0ba6fc2&e=e8ff1dad3e
