The FDA plans to ask an expert panel to come up with some guidelines for 1 of the next frontiers in cardiac rhythm management, the leadless pacemaker.
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ) have each developed tiny pacers designed for transcatheter placement within the heart, eliminating the need for the wire leads used with conventional pacemakers; Boston Scientific (NYSE:BSX), which put its S-ICD subcutaneous-lead pacemaker on the U.S. market in September 2012, is also working on a truly leadless pacing implant.
The FDA said its Circulatory System Devices panel is slated to meet Feb. 18, 2016, for a hearing on how clinical trials, post-approval studies and physician training requirements should be structured for the devices.
The federal safety watchdog said it wants the committee to recommend acceptable adverse event rates in acute and chronic care settings, and to lay out the indications for use, “given availability of other technologies with different adverse event profiles.”
The panel is also tasked with recommending training requirements for surgeons implanting the devices, plus “acceptability of observed learning curves for the new device type,” the FDA said. The circulatory devices panel will also be asked for recommendations on post-approval study requirements, the agency said.
In November, Medtronic said its Micra leadless pacemaker met the primary safety and effectiveness endpoints in a 725-patient trial by “wide margins.” The Micra device won CE Mark approval in the European Union last April.
St. Jude likewise reported meeting 6-month safety and efficacy endpoints last August for its leadless pacemaker entry, the Nanostim device, in the 526-patient Leadless II trial.
