Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ) are among medtech firms who have 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.
The panel is meeting on Feb. 18 in Gaithersburg, Md. to discuss leadless cardiac pacemaker device technology and make recommendations on clinical trial research, post-approval study design and training requirements for the devices.
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.
“St. Jude Medical is encouraged by the FDA’s interest in learning more about the potential of leadless pacing technology. The Nanostim leadless pacemaker was the world’s 1st commercially available leadless pacemaker and we look forward to presenting the clinical experience with the Nanostim leadless pacemaker to the FDA and outlining the robust training programs we’ve created to support physicians interested in providing the technology to their patients,” a St. Jude spokesperson told MassDevice.com.
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 November, Medtronic touted the results of a clinical trial of the device, saying it met its primary and secondary endpoints. Results from the trial were presented at the American Heart Association’s scientific sessions meeting this week and published in the New England Journal of Medicine, Medtronic said.
Medtronic said that 99.2% of patients in the trial were successfully implanted with the device. A total 96% of 725 patients experienced no major complications, which Medtronic said is 51% less than is seen in patients with conventional pacing systems.
Cardiac injuries occurred in 1.6% of patients, complications at the groin site in 0.7% and pacing issues in 0.3%. Medtronic said there were no dislodgments, no systemic infections and a 0.4% rate of system revisions.
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.
In August, St. Jude’s Nanostim met its 6-month safety and efficacy endpoints according to data presented at the annual meeting of the European Society of Cardiology in London.
The Leadless II study enrolled 526 patients in the primary cohort, with 300 completing the 6-month protocol in June. The entire group was followed for a mean 6.9 months, showing successful implantation of the Nanostim device in 504 (95.8%) of subjects, according to the NEJM paper. In some 29.8% of the cases, the Nanostim device needed repositioning; in 22 cases (4.4%) the device needed repositioning more than twice.
Nanostim met the primary safety endpoint in 280 of 300 patients (93.3%; 2-sided 95% CI, 89.9 to 95.9), with 22 device-related serious adverse events in 20 patients (6.7%) over a period of 6 months. The rate of device-related serious adverse events was 6.7%, including device dislodgement in 1.7% of patients, cardiac perforation in 1.3%, elevated pacing thresholds requiring device retrieval and reimplantation in 1.3%, and vascular complications in 1.3%.