Medtronic (NYSE:MDT), the world’s largest pure-play medical device company, won European regulatory approval for its Attain Performa cardiac lead portfolio.
The new product is designed to be paired with Medtronic’s Viva/Brava cardiac resynchronization therapy defibrillators, already on the market in Europe, to offer doctors more variation with electrode placement and pacing configuration. The Attain Performa product has 3 different lead configurations to account for different body shapes.
"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, medical director of Medtronic’s cardiac management division.
The Attain Performa line has not been approved by the FDA, but Medtronic is currently recruiting participants for a U.S. study. The company anticipates that it will have all the final data for this study by December 2014.
The CE Mark approval for Attain Performa comes on the heels of another win for Medtronic in Europe with the expanded approval its Resolute Integrity stent.