Boston Scientific receives CE mark approval for MRI compatible Accolade pacemakers and new CRT-Ps


Boston Scientific has announced the CE mark approval for the Accolade pacemaker family and for the Visionist and Valitude cardiac resynchronisation therapy pacemakers (CRT-P) with quadripolar pacing technology.

According to a company press release, the Accolade pacemakers enable patients to receive full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems, when implanted with its Ingevity leads.

The first Accolade device implant was performed by a team coordinated by Francesco Romeo, director of the Cardiology Department of Fondazione Policlinico Tor Vergata, Rome, Italy, and president-elect of the Italian Society of Cardiology.

“Thanks to the Accolade pacemaker family, I can offer my patients the best pacing therapies while giving them unparalleled access to imaging,” says Romeo. “Additionally, the full suite of diagnostics and the excellent longevity of the device mean that I should be able to utilise the device for my patients undergoing MRI scans in the future – many years from now.”

In addition to the CE mark approval and launch of the Accolade pacemaker family, Boston Scientific announced the CE mark approval for the Visionist and Valitude CRT-Ps with quadripolar pacing technology. When paired with the Acuity X4 pacing leads, these systems offer many options to reach and pace the target location in the left ventricle, potentially improving the patient response to CRT therapy. Stuart Harris, clinical director of the Essex Cardiothoracic Centre, Basildon, UK, performed the first implant of the Visionist X4 system.

The Accolade, Visionist, Valitude, and Acuity X4 devices are not available for sale in the USA.