Panel to Discuss FDA Role in Future Era of Leadless Pacing

Deborah Brauser

February 17, 2016

GAITHERSBURG, MD — An FDA advisory committee (AdCom) will be meeting tomorrow to discuss and debate ways to better evaluate and use new leadless cardiac pacemakers.

The FDA announced that topics scheduled to be brought up by the Circulatory System Devices Panel AdCom include how to better collect data both pre- and postapproval and possible device training requirements for clinicians.

In addition, "the committee will be asked to make recommendations on generally acceptable acute and chronic profiles of key adverse-event rates as well as indications for use for this device type," notes the agency.

As reported by heartwire from Medscape, two of these miniature devices are already fairly far along in development. The Micra leadless pacemaker (Medtronic) received CE Mark approval in April of last year based on the Micra TPS Global Clinical Trial.

The Nanostim leadless pacemaker (St Jude Medical) received its CE Mark in August 2013, based on the LEADLESS study. Representatives for both companies are scheduled to attend and make presentations at the panel meeting.

In addition to asking about "the clinical significance" or concerns for possible adverse-event rates from the devices vs traditional pacemakers, including cardiac perforation or pericardial effusion, other scheduled topics to be asked of the committee include:

  • How to identify patient subgroups who may be at risk for these adverse events.

  • How to best collect data, especially on long-term safety, in a postapproval setting.

  • What to do with these devices after end of life.

  • Recommendations for appropriate labeling or best practices.

  • How to best craft indications-for-use (IFU) statements.

In a statement submitted to the advisory panel, the American Heart Association (AHA) noted its support for the FDA in convening the meeting[1]. Although potential benefits and risks must be assessed before approval, these new devices "may provide patients and providers with an important new option in treating or preventing abnormal heart rhythms," they write.

Still, the AHA was adamant that the new leadless pacemakers "should have a safety profile that is as good as, if not better than, currently available devices" and there should be mandatory manufacturer-initiated training programs created.

The FDA executive summary memorandum and other meeting materials are posted on the organization's website.


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