Boston Scientific Corporation has announced CE mark approval and European market launch of the Ingevity family of magnetic resonance imaging (MRI) compatible pacing leads.
The Ingevity family offers 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, 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 on March 3rd by Daniel Gras, at the Nouvelles Cliniques Nantaises in Nantes, France. “The Ingevity MRI lead offers exceptional handling and placement within the heart,” says Gras. “In addition, the Boston Scientific ImageReady pacing system could help many patients who may require an MRI scan during their life.”
One of the first implants of the Autogen X4 CRT-D system incorporating all three of these new 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 mark approval demonstrates excellent performance including positive ratings on lead handling and manoeuvrability from 99.5% of implanters.
The INGEVITY trial series includes prospective, non-randomised, multicentre, global clinical studies to support the Ingevity family of leads for CE mark, FDA and other regulatory approvals. Over 1600 patients have been implanted at 78 centres 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 US.