Boston Scientific CRT lead
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific announces May 16 FDA market go-ahead for its Acuity Spiral left ventricular lead for cardiac resynchronization devices, such as its Cognis cardiac resynchronization therapy defibrillator (CRT-D) approved May 13 (1"The Gray Sheet" May 19, 2008, In Brief). Acuity Spiral has a spiral fixation design and small lead tip, tapering from size 4.1 French to 2.6 French. The company is sponsoring a five-year, 1,700-patient, 125-center registry to study the real-world performance of Acuity Spiral with the Latitude remote monitoring system. Acuity Spiral earned a CE mark in March (2"The Gray Sheet" March 10, 2008, p. 12)