CE Marking Approval and First Implants of MRI Pacing Leads Announced

A range of magnetic resonance imaging (MRI)-compatible pacing leads has received the European CE marking, and the company that developed the leads recently announced the European market launch.

The Ingevity range, developed by Boston Scientific Corp. (Natick, MA, USA), are a comprehensive 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, FormioMRI, AdvantioMRI, and Ingenio MRI pulse generators. When used with the Lattitude 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 on March 3, 2014, by Daniel Gras, MD, at the Nouvelles Cliniques Nantaises. “The Ingevity MRI lead offers exceptional handling and placement within the heart,” said Dr. Gras. “In addition, the Boston Scientific ImageReady pacing system could help many patients who may require an MRI scan during their life.”

“The Ingevity MRI pacing leads platform represents a significant milestone in our bradycardia technology and CRM lead portfolio,” said Michael Onuscheck, senior vice president and president, Boston Scientific Europe. “We are proud to offer multiple, new and innovative CRM leads engineered for superior long-term clinical performance, including Ingevity MRI pacing leads, 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 integrating all three of these new leads was performed by Dr. Gianluca Botto, head of cardiac electrophysiology and pacing at Sant'Anna Hospital (Como, Italy).

The subset of data from the Ingevity trial supporting CE marking approval demonstrated excellent performance including positive ratings on lead handling and maneuverability from 99.5% of implanters. The Ingevity trial series includes prospective, nonrandomized, multicenter, global clinical studies to support the Ingevity range of leads for CE marking, US Food and Drug Administration (FDA) and other regulatory approvals. Over 1600 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 yet available for sale in the United States.

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