The system is designed to simplify the implant procedure by combining three terminals into one integrated connector, further reducing the volume of the world’s smallest and thinnest high-energy CRT-Ds and ICDs. The Company announced CE mark and first implant of this system in May 2009.
“Boston Scientific commissioned a prospective, multicentre observational clinical study involving more than 400 patients to extensively evaluate the 4-Site system and to demonstrate appropriate clinical performance before making it broadly available in Europe,” said Poul Erik Bloch Thomsen, Gentofte University Hospital, Copenhagen, Denmark. “The study examined both shocking and pacing performances and showed that the 4-Site system increased the simplicity and overall efficiency of the implant procedure, and further reduced the already low likelihood of complications arising from connections being reversed.”
