Boston Scientific announces pacemaker CE mark with options for magnetic resonance imaging

MARLBOROUGH, Mass., Oct. 16, 2014 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for the ACCOLADETM pacemaker family. When implanted with the company's INGEVITYTM 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. In addition, the Boston Scientific ImageReadyTM technology offers the most flexible MRI options, allowing higher energy scan sequences, and featuring a programmable MRI timer designed to improve patient workflow. (1)(2)(3)(4)(5)

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). "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."

In addition to the CE mark approval and launch of the ACCOLADE pacemaker family, Boston Scientific received CE Mark approval for the VISIONISTTM and VALITUDETM CRT-Ps with quadripolar pacing technology. When paired with the ACUITYTM 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.(6) Dr. Stuart Harris, Clinical Director of the Essex Cardiothoracic Centre, Basildon, UK, performed the first implant of the VISIONIST X4 system.

"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."                                           

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 ACCOLADE, VISIONIST, VALITUDE, AUTOGEN, ORIGEN, INGEVITY, and ACUITY X4 devices are not available for sale in the U.S.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world.  As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. 

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(1) Boston Scientific: Physician Technical Manual 359250-001 EN Europe 2014-05

(2) MDT ADVISA DR MRI™ SURESCAN™ A3DR01 Clinician Manual M939188A001C 2010-01-28)

(3) St. Jude Medical Accent Model PM1210 Spec Sheet (G0205), Accent Brochure (G0221)

(4) Biotronik: Epyra 8 HF-T, eGA-HW_403588-D Epyra (ProMRI) p. 35

(5) Sorin Kora 100 Implant Manual, 2013-09 U199A

(6) Left Ventricular Lead Position and Clinical Outcome in the Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Therapy (MADIT CRT Sub-study)