The FDA approved Boston Scientific’s Acuity X4 quadripolar left ventricular leads on Feb. 23.
In April 2014, Boston Scientific received FDA approval for its X4 line of quadripolar cardiac resynchronization therapy devices.
The approval of the quadripolar leads was based on a prospective, non-randomized, multicenter study that enrolled 764 patients. During six months of follow-up, the study met its primary safety and efficacy endpoints, according to Boston Scientific.
The company also initiated a study earlier in February to support FDA approval for the use of MRI in its approved implanted cardiac defibrillation and cardiac resynchronization therapy systems. The study will enroll as many as 500 patients at approximately 60 sites and will use the quadripolar leads.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.