Interventional device developer Boston Scientific has received clearance from the U.S. Food and Drug Administration (FDA) for its Acuity Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, the Natick, MA-based company said.
Acuity Spiral features a spiral fixation design and small lead tip profile for placement of the lead in veins of varying sizes, including difficult-to-access veins.
Boston Scientific is also conducting a prospective, multicenter trial designed to collect and analyze real-world performance data for Acuity. The study will enroll approximately 1,700 patients in up to 125 centers. Patients will be followed over a period of five years and will also be tracked via Boston Scientific's Latitude Patient Management system, according to the company.
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