The European Union has given its stamp of approval, the CE mark, to Medtronic Inc.’s Attain Performa portfolio of quadripolar leads. The company immediately will launch the devices in Europe. Attain Performa left-heart leads are designed to be paired with Medtronic’s Viva and Brava quad cardiac resynchronization therapy defibrillators (CRT-Ds). According to the company, the pairing provides additional options for physicians as they navigate different patient anatomies, optimizing therapy based on the individual needs of heart failure patients. The leads feature four electrodes with 16 pacing configurations, which also aid in personalization. They 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., director of the cardiovascular department at S. Filippo Neri Hospital in Rome, Italy, and president of the World Society of Arrhythmias.

The Attain Performa portfolio includes three distinct lead shapes: dual cant, s-shape and straight, each of which has the 16 pacing configurations. The leads are designed with shorter spacing between the two center electrodes to increase phrenic nerve thresholds and reduce phrenic nerve stimulation (PNS). The phrenic nerve originates in the neck and passes down between the lung and heart to reach the diaphragm. If the phrenic nerve inadvertently is stimulated, it activates the diaphragm muscle and could cause muscle twitching, hiccups or shortness of breath. With unipolar and bipolar leads, PNS may require surgery to reposition the lead or disable the CRT; according to Medtronic, quadripolar leads reduce the likelihood of PNS occurring.

The capability for steroid elution is included on all four electrodes, which lowers chronic pain thresholds as well as reducing the likelihood of PNS. The leads also use Vectorexpress technology, an automated in-office test that reportedly provides information on physician-selected pacing configurations in less than three minutes to help select the optimal pacing configuration for heart stimulation.

“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., 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.”

The leads are in an ongoing global clinical trial—the Attain Performa Quadripolar Lead study, which is gathering additional safety and effectiveness data on Attain Performa leads in patients needing 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 already have occurred in Australia, Europe, South America and the United States.

Medtronic is headquartered in Minneapolis, Minn., and makes medical devices in a broad range of specialties.

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