Boston Scientific
Corporation BSX has received CE Mark approval for the ACCOLADE(TM)
pacemaker family. When implanted with the company's INGEVITY(TM) 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 ImageReady(TM) technology offers the most flexible MRI options,
allowing higher energy scan sequences, and featuring a programmable MRI
timer designed to improve patient workflow.(12345)
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 VISIONIST(TM)
and VALITUDE(TM) CRT-Ps with quadripolar pacing technology. When paired with
the ACUITY(TM) 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(TM),
DYNAGEN(TM), INOGEN(TM), and ORIGEN(TM) CRT-Ds, and lead technologies such
as the INGEVITY(TM), RELIANCE(TM), and ACUITY(TM) leads.
The ACCOLADE, VISIONIST, VALITUDE, AUTOGEN, ORIGEN, INGEVITY, and ACUITY X4
devices are not available for sale in the U.S.
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