The FDA is hosting a panel meeting on leadless pacemaker devices, looking to St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) to join the discussion and make recommendations on acceptable guidelines on the devices.
The panel committee will seek recommendations on clinical trial and post approval study design and physician training, and will be asked to make recommendations on generally acceptable acute and chronic profiles of key adverse event rates and indications for use with leadless pacers.
The FDA drafted up a series of questions for the panel, covering the rates of adverse events in leadless versus traditional pacemakers, how to collect data from acute performance and implant experience post-approval, long-term performance monitoring, how to handle the devices after end of life and indications for use.
The panel is meeting on Feb. 18 in Gaithersburg, Md.
Last week, St. Jude and Medtronic said they will present data on their leadless pacing systems, the Micra and Nanostim, at an FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee.
Medtronic will present data on its Micra transcatheter pacing system and St. Jude will present data on its Nanostim leadless pacemaker, with both companies touting clinical results published in the New England Journal of Medicine.
Fridley, Minn.-based Medtronic’s Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. The Micra device has an estimated 12-year battery life and is approved as safe for full-body MRI scans, the company said.
In similar fashion, St. Jude’s Nanostim pacemaker is designed to be placed inside the heart of a cardiac patient in a percutaneous, catheter-based procedure. The device is leadless, and therefore isn’t connected to the heart muscle via wires, a modification over previous models that the company touts as major safety improvement.