Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its line of quadripolar, MRI-safe cardiac resynchronization therapy pacemakers.
The approval covers Medtronic’s Percepta, Serena and Solara devices, the Fridley, Minn.-based company said. The devices are slated to the hit the European market in March.
“With the addition of quadripolar CRT-P devices to our heart failure portfolio, we now offer a comprehensive line of CRT devices to further meet the needs of patients throughout Europe,” heart failure GM Dr. David Steinhaus said in prepared remarks. “Our new quadripolar CRT-P devices include advanced, smart technologies that allow physicians to provide each patient with the appropriate therapy specific to his or her individual needs, all while offering access to advanced life-saving MRI technologies.”
“Quadripolar devices, such as these new pacemakers, allow more pacing programming options, which allows us to better optimize CRT delivery,” added Dr. Massimo Mantica of Milan’s Istituto Clinica Sant’Ambrogio. “Advanced technology continues to give us smarter devices that enable more personalized treatment for patients.”
Last October, Medtronic got the green light from the FDA for its full suite of MRI-safe cardiac rhythm and heart failure devices, touting it as the 1st approval of its kind in the U.S.
In January, the U.S. Centers for Medicare & Medicaid Services issued a national coverage determination for leadless cardiac pacemakers, including Medtronic’s Micra device. Last week Japanese regulators approved Micra, which at roughly the size of a large vitamin (1/10th the size of a conventional device) is claimed as the world’s smallest pacemaker. The FDA approved Micra in April 2016.