FDA approves Boston Scientific’s quadripolar leads

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.