This is the first DEB accepted by the FDA for its 'Breakthrough Program'.
- This is the first DEB accepted by the FDA for its 'Breakthrough Program'.
- "This first patient was treated with the investigational device after suffering a DES ISR.
- We are delighted to be able to offer our patients this promising new technology," commented Professor Pascal Vranckx, Hartcentrum Hasselt, Belgium.
- "No coronary drug-eluting balloon has yet been approved in the US, where ISR currently represents 11% of all stent implantations.