Medtronic, Inc. MDT today announced it
has received CE (Conformité Européenne) Mark and will begin the European
launch of the Attain Performa^® portfolio of quadripolar leads. Paired with
Medtronic Viva^®/Brava^® Quad cardiac resynchronization therapy defibrillators
(CRT-D), Attain Performa left-heart leads provide additional options for
physicians as they navigate different patient anatomies, optimizing therapy
based on the individual needs of heart failure patients.
Attain Performa leads feature four electrodes with 16 pacing configurations.
Compared to unipolar and bipolar leads, the additional pacing configurations
offered by Medtronic quadripolar leads provide implanting physicians more
options to optimize CRT delivery. Attain Performa leads are not approved
for sale in the United States.
"This sophisticated new lead family provides physicians with the flexibility
needed to effectively navigate diverse patient anatomies and help maintain
optimal lead position, which has been proven to improve CRT response," said
Massimo Santini, M.D., FESC, FACC, FACA, director, Cardiovascular Department,
S. Filippo Neri Hospital in Rome, and president, World Society of Arrhythmias.
The Attain Performa portfolio includes three distinct lead shapes, Dual Cant,
S-Shape and Straight, each with 16 pacing configurations to better fit a
patient's anatomy and optimize CRT delivery. The leads are designed with
shorter spacing between the two center electrodes to increase phrenic nerve
thresholds and reduce phrenic nerve stimulation (PNS).^[1] With unipolar and
bipolar leads, PNS may require surgery to reposition the lead or disable the
CRT, and occurs when a device's electrical output inadvertently activates the
diaphragm muscle, causing muscle twitching, hiccups or shortness of breath.
Attain Performa leads include steroid elution on all four electrodes for lower
chronic pacing thresholds, which contribute to greater device longevity and
reduce the likelihood of PNS.^[2] The leads also utilize VectorExpress(TM)
technology, an automated in-office test that provides information on
physician-selected pacing configurations in less than three minutes to aid in
selecting the optimal pacing configuration for stimulating the heart.
Attain Performa leads are compatible with the company's newest portfolio of
devices, Viva Quad CRT-Ds, which feature the AdaptivCRT^® algorithm that
significantly improves heart failure patients' response rate to therapy by
preserving normal heart rhythms and continuously adapting to patient needs.
"Our new quadripolar leads were designed with advancements that help
physicians customize care for their heart failure patients so they receive the
optimal therapy for their condition," said David Steinhaus, M.D., vice
president and general manager, Heart Failure, and medical director for the
Cardiac Rhythm Disease Management business at Medtronic. "The Attain Performa
portfolio builds upon years of Medtronic leadership driving advancements in
CRT and significantly improving the lives of heart failure patients at every
stage of care."
Attain Performa Quadripolar Lead Study
The Attain Performa Quadripolar Lead study is a global clinical trial
gathering additional safety and effectiveness data on Attain Performa leads in
patients indicated for a CRT-D. Approximately 140 centers throughout the
world, in regions including the United States, Canada, Europe, Australia and
developing markets, will enroll up to 1,210 patients who will receive Attain
Performa leads in this open-label, single-arm study. Enrollments have already
occurred in Australia, Europe, South America and the United States.
In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias.
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