US-based medical equipment manufacturer Boston Scientific has obtained CE Mark approval for its Accolade pacemaker family of devices.
Accolade pacemakers have been designed to allow patients to receive full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems, when implanted with the company's Ingevity leads.
The company's ImageReady technology provides the most flexible MRI options, allowing higher energy scan sequences, and featuring a programmable MRI timer designed to improve patient workflow.
The first Accolade device implant was carried out by a team coordinated by professor Francesco Romeo, director of the Cardiology Department of Fondazione Policlinico Tor Vergata, Rome.
Romeo said: "Thanks to the Accolade pacemaker family, I can offer my patients the best pacing therapies while giving them unparalleled access to imaging.
"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."
The company has also received the CE Mark of approval for its Visionist and Valitude CRT-Ps with quadripolar pacing technology.
Boston Scientific executive vice-president Joe Fitzgerald said: "We have prioritised investments and now have the first and only subcutaneous ICD, the smallest ICD, and the longest-lasting pacemaker, ICD and CRT devices in the world.
"Now, with the Accolade pacemaker family, we also offer the most flexible MRI conditional pacemaker system, along with advanced diagnostics that assist physicians in detecting atrial arrhythmias."
Both systems provide several options to reach and pace the target location in the left ventricle, when paired with the Acuity X4 pacing leads.
The company said that Accolade, Visionist, Valitude, Origen, Ingevity, and Acuity X4 devices are not yet available for sale in the US.