Lead for Heart Failure Launched by Boston Scientific
The new ACUITY lead from Boston Scientific was approved by the Food and Drug Administration. The system is indicated for use among patients with cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D) for the treatment of heart failure. Boston Scientific posted news of the approval on their website.
The ACUITY has a spiral fixation design and a small lead tip profile, a 4.1 French that tapers to a 2.6 French. This supports placement of the lead within differently sized veins, including those which can be challenging for lead placement.
Leads are insulated wires which carry heart signals to a device implanted. These also deliver energy from the implanted device to the heart. Leads are most often passed through veins to reach the heart. Notably, the lead has the smallest left ventricular tip profile that is currently available. This feature further supports device placement.
Data submitted to the FDA indicates that the new lead is associated with excellent stability following implantation. Another trial with the device is underway, a multi-center prospective study to collect performance data in the real world on the ACUITY. About 125 centers are participating in the trial with a target enrollment of 1,700 patients.
The ACUITY Spiral left ventricular lead is the company’s fifth generation ventricular lead product and the second in the ACUITY product line.
May 21, 2008 Related topics: Product Approval & Certification, Cardiology