- OUR VIEW
- LEARNING CENTER
Welcome @Briefingcom Followers!
$MDT: Medtronic CoreValve System gains first approval for transcatheter valve-in-valve procedures (51.53)
Co announces it has received Conformit? Europ?enne Mark for valve-in-valve procedures using the CoreValve and CoreValve? Evolut(TM) transcatheter aortic valve implantation systems in degenerated bioprosthetic surgical aortic valves. This is the first ever regulatory approval for VIV procedures, which provide a minimally invasive treatment option for patients whose surgical aortic valves have degenerated, and who are at extreme or high risk for surgery and would otherwise go untreated. The CoreValve VIV procedures are not approved in the United States.
Results from the largest global VIV registry, published in Circulation in November showed the VIV approach resulted in considerable hemodynamic improvements, including a decrease in valve gradients (blood flow resistance). Positive procedural outcomes were maintained at 1-year follow-up (with 89% survival at one year), which was comparable with other non-VIV TAVI studies.