The approval covers Medtronic’s Percepta, Serena and Solara devices, the Fridley, Minn.-based company said. The devices are slated tho hit the U.S. market in “early summer,” Medtronic said. In February the company said it had won CE Mark approval in the European Union for the MRI-safe quad pacer line and planned a March debut.
“Developing cardiac devices so physicians have the best treatment options to meet the individual needs of their patients is at the core of everything we do,” heart failure GM Dr. David Steinhaus said in prepared remarks. “With FDA approval of these quadripolar CRT-P devices, we can offer the most innovative pacing technology for improved patient outcomes and enhanced design for their comfort.”
“These new pacemakers allow clinicians to provide more personalized therapy treatment options,” added Dr. Anne Curtis of the University at Buffalo, N.Y. “Their ability to automatically adjust pacing to meet the patient’s needs, even those who are among the most difficult to treat, is an example of how advanced implanted heart device technology has become.”
Last October, Medtronic got the green light from the FDA for 3T scanning of 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.