Boston Scientific Corporation has initiated the RESPOND Post Market
Registry to assess real world performance of the Lotus Valve System.
The RESPOND Registry will collect data on clinical outcomes and device
performance in 1,000 patients implanted at 50 centres around the world.
Three patients enrolled in the RESPOND Registry thus far have been successfully implanted with the Lotus Valve System. Dr. Nicolas Van Mieghem and Prof. Peter De Jaegere led the first transcatheter aortic valve implantation (TAVI) procedure at Erasmus Medical Centre in Rotterdam, the Netherlands using the Boston Scientific Safari Pre-Shaped TAVI Guidewire. The Safari Guidewire, which received FDA clearance and CE Mark in 2013, is compatible with the Lotus Valve System and other TAVI devices and is designed to facilitate stable, atraumatic valve placement.
Three patients enrolled in the RESPOND Registry thus far have been successfully implanted with the Lotus Valve System. Dr. Nicolas Van Mieghem and Prof. Peter De Jaegere led the first transcatheter aortic valve implantation (TAVI) procedure at Erasmus Medical Centre in Rotterdam, the Netherlands using the Boston Scientific Safari Pre-Shaped TAVI Guidewire. The Safari Guidewire, which received FDA clearance and CE Mark in 2013, is compatible with the Lotus Valve System and other TAVI devices and is designed to facilitate stable, atraumatic valve placement.
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