The FDA has approved Boston Scientific’s Acuity Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure.
The Acuity Spiral is the company's fifth generation left ventricular lead and second in the Acuity family of left ventricular leads, according to the Natick, Mass.-based company.
Boston Scientific said its product features a spiral fixation design and small lead tip profile (4.1 French tapering to 2.6 French) for placement of the lead in veins of varying sizes, including difficult-to-access veins.
The company said it is also conducting a prospective, multi-center trial designed to collect and analyze real-world performance data for the Acuity Spiral lead, enrolling approximately 1,700 patients in up to 125 centers. Boston Scientific also noted that the patients will be monitored over a period of five years and will be enrolled on its Latitude Patient Management system, enabling wireless remote management of patients.