CE Mark for Boston’s Pacemaker Opens MRI Conditionality Options

Boston Scientific Corporation has gained CE Mark approval for the ACCOLADE™  pacemaker family with MRI conditionality.


When implanted with the company’s INGEVITY™  leads, ACCOLADE pacemakers are the first to enable patients to receive full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems. 

Boston Scientific has also received 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.

In addition, Boston Scientific is actively pursuing MRI compatibility for our existing implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy defibrillators (CRT-D), including the AUTOGEN™, DYNAGEN™, INOGEN™, and ORIGEN™ CRT-Ds, and lead technologies such as the INGEVITY™, RELIANCE™, and ACUITY™ leads.

The first ACCOLADE device implant was performed by a team coordinated by Prof. Francesco Romeo, Director of the Cardiology Department of Fondazione Policlinico Tor Vergata, Rome, and President-Elect of Italian Society of Cardiology (SIC).


Physician comments

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

Company comments

“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,” said Joe Fitzgerald, executive vice president and president, Rhythm Management. “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.”

Source: Boston Scientific Corporation, PR Newswire

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