Boston Scientific (NYSE:BSX) said it won CE Mark approval in the European Union for its Accolade line of MRI-safe pacemakers, touting the devices as the 1st to allow full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems when used with its Ingevity leads.
The Accolade devices also feature Boston Scientific’s ImageReady technology, designed to allow more flexible MRI options, higher energy scan sequences and a programmable MRI timer, according to a press release.
Marlborough, Mass.-based Boston Scientific also said it won CE Mark approval for its quadripolar Visionist and Valitude CRT-Ps.
"We have prioritized 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," rhythm management president Joe Fitzgerald said in prepared remarks. "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. We believe that the provision of automatic daily monitoring and advanced diagnostics to our pacemaker devices will help physicians identify atrial fibrillation sooner, enabling them to initiate patient anti-coagulation therapy to reduce the risk of stroke."
The company said it’s also "actively pursuing" MRI compatibility for its implantable cardioverter defibrillators, cardiac resynchronization therapy defibrillators and leads for those devices.