CE Mark And European Launch Of Attain Performa® Quadripolar Leads

In short

Medtronic, Inc. has received CE Mark approval for its Attain Performa® portfolio of quadripolar leads and will immediately begin the European launch. Paired with Medtronic Viva®/Brava® Quad cardiac resynchronization therapy defibrillators (CRT-D), the company says its Attain Performa left-heart leads provide additional options for physicians as they navigate different patient anatomies to address the individual needs of heart failure patients.

Background

Compared to unipolar and bipolar leads, Attain Performa features four electrodes with 16 pacing configurations. Medtronic says, coupled with its three distinct lead shapes this provides implanting physicians with more options to optimise CRT delivery.

Furthermore the leads are designed with shorter spacing between the two center electrodes to increase phrenic nerve thresholds and reduce phrenic nerve stimulation (PNS). 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 a reduced likelihood of PNS. The leads also utilize 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.

The new leads are compatible with Medtronic’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.

To back up its claimed advantages, Medtronic is undertaking 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.

Physician comments

“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.

Company comments

“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.”

Regulatory status

Attain Performa leads are not approved for sale in the United States.