On 5 March, Medtronic received CE mark of the Attain Performa portfolio of quadripolar leads. The company announced that it will initiate launch in Europe.
Paired with Medtronic Viva/Brava Quad cardiac resynchronisation therapy defibrillators (CRT-D), Attain Performa left-heart leads provide additional options for physicians as they navigate different patient anatomies.
Attain Performa leads feature four electrodes with 16 pacing configurations including three distinct lead shapes, Dual Cant, S-Shape and Straight. Compared to unipolar and bipolar leads, the additional pacing configurations offered by Medtronic quadripolar leads provide implanting physicians more options to optimise CRT delivery.
“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, director, Cardiovascular Department, S Filippo Neri Hospital in Rome, and president, World Society of Arrhythmias.
The Attain Performa leads are designed with shorter spacing between the two centre electrodes to increase phrenic nerve thresholds and reduce phrenic nerve stimulation, a company release states.
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 phrenic nerve stimulation.
The leads also utilise VectorExpress 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 customise care for their heart failure patients so they receive the optimal therapy for their condition,” said David Steinhaus, vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic.
The Attain Performa leads are not yet approved for sale in the United States
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 centres throughout the world, in regions including the United States, Canada, Europe, Australia and developing markets, will enrol up to 1,210 patients who will receive Attain Performa leads in this open-label, single-arm study. Enrolments have already occurred in Australia, Europe, South America and the United States.