FDA Backs ACUITY X4 Quadripolar Left Ventricular Leads

Boston Scientific secured FDA approval for the ACUITY X4 quadripolar left ventricular leads, the device company announced yesterday.

This is the first time Boston Scientific will commercialize a full X4 CRT system in the U.S. market. The approval was based on data from the NAVIGATE X4 study that enrolled 764 patients.

The company also started its global ENABLE MRI study earlier this month, which is designed to back FDA approval for MRI across ICD and CRT systems and expand MRI labeling to the U.S. and Asia. — Anisa Jibrell