CE Marking Earned, First Implants Done of Boston Scientific Ingevity MRI Pacing Leads

 

March 21, 2014
Boston Scientific Ingevity Leads MRI Systems Pacemakers CRT EP Lab

March 21, 2014 — Boston Scientific Corp. received CE marking and launched in Europe the Ingevity family of magnetic resonance imaging (MRI) compatible pacing leads. The Ingevity family is a set of leads that can be placed using a 6 French introducer, including passive and active fixation models. Ingevity MRI pacing leads are part of the ImageReady MR-conditional pacemaker system, which includes Vitalio MRI, Formio MRI, Advantio MRI and Ingenio MRI pulse generators. When used with the Latitude NXT patient management system, these devices wirelessly monitor patients for conditions such as atrial arrhythmias.

The first implant of the Ingevity MRI lead was performed March 3 by Daniel Gras, M.D., at the Nouvelles Cliniques Nantaises in Nantes, France.

Other Boston Scientific CRM leads engineered for superior long-term clinical performance including the Reliance 4-Front defibrillation leads and the Acuity X4 CRT family of leads. One of the first implants of the Autogen X4 CRT-D system incorporating all three of these leads was performed by Gianluca Botto, head of cardiac electrophysiology and pacing at Sant'Anna Hospital in Como, Italy.

The subset of data from the Ingevity trial supporting CE marking demonstrates positive ratings on lead handling and maneuverability from 99.5 percent of implanters.

The Ingevity trial series includes prospective, non-randomized, multi-center, global clinical studies to support the Ingevity family of leads for CE marking, U.S. Food and Drug Administration (FDA) and other regulatory approvals. More than 1,600 patients have been implanted at 78 centers in 16 countries.

Ingevity MRI, Reliance 4-FRONT, Acuity X4, and Autogen X4 CRT-D are investigational devices and not available for sale in the United States. 

For more information: www.bostonscientific.com