Boston Scientific Corporation (NYSE: BSX) announces CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads. Pacing leads are insulated wires that connect an implantable pacemaker to the heart for treatment of bradycardia, a condition in which the heart beats too slowly. Pacemakers work in conjunction with leads to sense and stimulate (or pace) the heart.
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, M.D., at the Nouvelles Cliniques Nantaises in Nantes, France. "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 incorporating all three of these new leads was performed by Dr 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 maneuverability from 99.5% of implanters.[1]
The INGEVITY trial series includes prospective, non-randomized, multi-center, 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 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 U.S.
[1]INGEVITY Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study. Data on file.