Dr. King, president of the Heart and Vascular Institute at Saint Joseph’s Health System in Atlanta, has developed several devices widely used in interventional cardiology. He shook his head in amazement at the speed at which the European regulatory agency operated in this case, noting that EU marketing approval for the Valtech Cardioband device was granted and a payment structure was almost immediately established on the basis of a 50-patient, first-in-man study.
“The data are very consistent. I think that‘s what made the difference,” Dr. Kuck said.
The study was funded by Valtech. Dr. Kuck reported serving as a consultant to Biosense Webster, Edwards, and St. Jude, and on a speakers’ bureau for Medtronic.