Boston Scientific Wins EU Approval for Leads Compatible with MRIs

Boston Scientific continues to rack up European approvals.  

The Natick, MA-based company says it's Ingevity family of MRI-compatible pacing leads now has CE Mark approval and has been launched in the European market.

The first implant of the Ingevity lead was performed on March 3, by Daniel Gras, MD, at the Nouvelles Cliniques Nantaises (Nantes, France).

The Ingevity news came around the same time Boston Scientific announced CE Mark approval for its Rebel bare-metal stent. 

The Ingevity series is specifically engineered to be compatible with magnetic resonance imaging (MRI). The series is available in both passive and active fixation models. Boston Scientific says the leads can be placed using a 6Fr introducer.

"The Ingevity MRI lead offers exceptional handling and placement within the heart," said Gras. "In addition, the Boston Scientific ImageReady pacing system could help many patients who may require an MRI scan during their life."

Pacing leads are the insulated wires that connect an implanted pacemaker to a patient's heart to both sense when the pacemaker needs to deliver a pulse and to actually deliver that pulse. Pacemakers are implanted as a treatment for bradycardia, a condition in which the heart beats too slowly.

Earlier non-MRI-compatible pacemakers and leads can be very dangerous to the wearer should MRI be attempted. Not only can the powerful magnet in the MRI machine scramble the brain of the pacemaker, but the magnetic energy can cause the leads to heat, damaging them and potentially causing burns to the patient.

Boston Scientific says that data from the Ingevity trial supporting CE mark approval demonstrates the excellent performance of the leads, including positive ratings on lead handling and maneuverability from 99.5 percent of implanters.

Ingevity MRI pacing leads are part of the ImageReady MR Conditional pacing system, which includes the  Vitalio MRI, Formio MRI, Advantio MRI, and Ingenio MRI pulse generators. When used with the company's Latitude NXT patient management system, patients can be remotely and wirelessly monitored for conditions such as atrial arrhythmias, which reduces the followup burden on both the clinic and the patient.

The Ingevity MRI series of pacing leads is currently classified as an investigational device by FDA. Therefore these leads are not available for sale in the United States.

On a side note, Boston Scientific has been exploring leadless pacemakers, which could potentially do away with the need for a product such as Ingevity. St. Jude Medical meanwhile has been racing to commercialize its Nanostim leadless pacemaker, and Medtronic has its Micra leadless pacemaker.

Stephen Levy is a contributor to Qmed and MPMN.