Boston Scientific Corporation announced that it will be completing the study of ACUITY Spiral Left Ventricular Lead by August 2016.
Acuity spiral lead is a steroid-eluting lead. The device is used in heart failure where positioning of leads in the heart is required. The product features a spiral design and small lead tip profile (4 French) for placement of the lead even in difficult-to-access veins of varying sizes. A lead is an insulated wire that carries the heart signal to the implanted device and delivers energy from the device to the heart. In most cases, leads are passed into the heart through veins.
The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral LV Lead. The 1700 patient, phase IV study is currently recruiting participants. The official title of the study is “Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead”.